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Trial record 13 of 99 for:    FEC

Clinical Value of FEC-PET Combined With Endorectal MRI for Pre-therapeutic Staging of Prostate Cancer (FEC-PET/MRI)

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ClinicalTrials.gov Identifier: NCT00520546
Recruitment Status : Completed
First Posted : August 24, 2007
Results First Posted : June 20, 2012
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Markus Hartenbach, German Federal Armed Forces

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Prostate Cancer
Interventions Other: 18F-Ethylcholine Positron Emission Tomography (FEC-PET)
Other: Endorectal Magnetic Resonance Imaging (1.5Tesla) (eMRI)
Enrollment 44
Recruitment Details Enrollment of first patient: 18th. December, 2007 Completion by last patient: 12th. January, 2011 Single Center Study at Federal Armed Forces Hospital Ulm
Pre-assignment Details 44 patients were enrolled, 38 patients completed the study. 1 patient decided not to choose prostatectomy after Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI), although it was planned at point of enrollment. 5 patients did not get a PET/MRI-can because of failed radiopharmaceutical synthesis of [18F]fluoroethylcholine (FEC).
Arm/Group Title FEC-PET/eMRI
Hide Arm/Group Description The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
Period Title: Overall Study
Started 44
Completed 38
Not Completed 6
Reason Not Completed
Withdrawal by Subject             1
failed radiopharmaceut. synthesis of FEC             5
Arm/Group Title FEC-PET/eMRI
Hide Arm/Group Description The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
<=18 years
0
   0.0%
Between 18 and 65 years
23
  52.3%
>=65 years
21
  47.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
65  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
0
   0.0%
Male
44
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 44 participants
44
1.Primary Outcome
Title Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings
Hide Description PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. At least 1 histological confirmed cancer lesion has to be detected by each of the 3 methods to be patient based true positive.
Time Frame within < 2 weeks after PET/MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Comparison of imaging results (FEC-PET, MRI and PET/MRI) with postoperative histological findings (all patients).
Arm/Group Title [18F]Fluoroethylcholine Positron-Emission-Tomography (FEC-PET) Magnetic Resonance Imaging (MRI) PositronEmissionTomography/MagneticResonanceImaging (PET/MRI)
Hide Arm/Group Description:
PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a "cold" transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure.
The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2 weighted (T2w) turbo spin echo (TSE) transversal and a coronal short-tau inversion recovery (STIR) sequence. For prostate assessment, 3mm endorectal T2 weighed (T2w) spin echo (SE) sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
PET images at 45 min p.i. (post injection) and 65 min p.i. were fused with transversal endorectal and QBody T2 weighed (T2w) MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
Overall Number of Participants Analyzed 38 38 38
Measure Type: Number
Unit of Measure: participants
True Positive 36 26 35
False Positive 1 1 0
True Negative 0 0 1
False Negative 1 11 2
Total True 36 27 36
Total False 2 11 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection [18F]Fluoroethylcholine Positron-Emission-Tomography (FEC-PET)
Comments

results from FEC-PET as compared with histological results on a patient based analysis

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0526
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter sensitivity
Estimated Value 97
Confidence Interval (2-Sided) 95%
86 to 100
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection [18F]Fluoroethylcholine Positron-Emission-Tomography (FEC-PET)
Comments

results from FEC-PET as compared with histological results on a patient based analysis

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0526
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter specificity
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 98
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection [18F]Fluoroethylcholine Positron-Emission-Tomography (FEC-PET)
Comments

results from FEC-PET as compared with histological results on a patient based analysis

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0526
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter accuracy
Estimated Value 95
Confidence Interval (2-Sided) 95%
82 to 99
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

results from MRI as compared with histological results on a patient based analysis

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter sensitivity
Estimated Value 70
Confidence Interval (2-Sided) 95%
53 to 84
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

results from MRI as compared with histological results on a patient based analysis

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter specificity
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 98
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

results from MRI as compared with histological results on a patient based analysis

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter accuracy
Estimated Value 68
Confidence Interval (2-Sided) 95%
51 to 83
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PositronEmissionTomography/MagneticResonanceImaging (PET/MRI)
Comments

results from PET/MRI as compared with histological results on a patient based analysis

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0043
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter sensitivity
Estimated Value 95
Confidence Interval (2-Sided) 95%
82 to 99
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PositronEmissionTomography/MagneticResonanceImaging (PET/MRI)
Comments

results from PET/MRI as compared with histological results on a patient based analysis

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0043
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter specificity
Estimated Value 100
Confidence Interval (2-Sided) 95%
3 to 100
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PositronEmissionTomography/MagneticResonanceImaging (PET/MRI)
Comments

results from PET/MRI as compared with histological results on a patient based analysis

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0043
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter accuracy
Estimated Value 95
Confidence Interval (2-Sided) 95%
82 to 99
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients
Hide Description PET positive lesions (n=128) were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined.
Time Frame within < 2 weeks after PET/MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Comparison of lesion based (128)imaging results (FEC-PET, MRI and PET/MRI) with postoperative histological findings (all patients = 38).
Arm/Group Title FEC-PET Magnetic Resonance Imaging (MRI) PET/MRI
Hide Arm/Group Description:
PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a "cold" transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure.
The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
Overall Number of Participants Analyzed 38 38 38
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
128 128 128
Measure Type: Number
Unit of Measure: lesions
True positive 59 40 55
False positive 26 27 8
True negative 19 18 37
False negative 24 43 28
Total true 78 58 92
Total false 50 70 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter positive prediction
Estimated Value 69
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter negative prediction
Estimated Value 44
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter sensitivity
Estimated Value 71
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter specificity
Estimated Value 42
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter accuracy
Estimated Value 61
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter positive prediction
Estimated Value 60
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter negative prediction
Estimated Value 30
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter sensitivity
Estimated Value 48
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter specificity
Estimated Value 40
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter accuracy
Estimated Value 45
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter positive prediction
Estimated Value 87
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter negative prediction
Estimated Value 57
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter sensitivity
Estimated Value 66
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter specificity
Estimated Value 82
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter accuracy
Estimated Value 72
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3)
Hide Description PET positive lesions in patients with Gleason >6(3+3),n=43 were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative & positive predictive values were determined.
Time Frame within < 2 weeks after PET/MRI
Hide Outcome Measure Data
Hide Analysis Population Description

lesion based (patients with Gleasons Score >6(3+3),n= 43) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38).

Gleason Grades: 1+2=well differentiated (rare), 3=moderately diff., 4=poorly diff., 5=undifferentiated

Gleason Score = histological primary grade + secondary grade (min=2,max=10)

Arm/Group Title FEC-PET Magnetic Resonance Imaging (MRI) PET/MRI
Hide Arm/Group Description:
PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a "cold" transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure.
The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
Overall Number of Participants Analyzed 38 38 38
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
43 43 43
Measure Type: Number
Unit of Measure: lesions
True positive 27 22 27
False positive 5 9 1
True negative 8 4 11
False negative 3 8 4
Total true 35 26 38
Total false 8 17 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter positive prediction
Estimated Value 84
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter negative prediction
Estimated Value 73
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter sensitivity
Estimated Value 90
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter specificity
Estimated Value 84
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter accuracy
Estimated Value 82
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter positive prediction
Estimated Value 71
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter negative prediction
Estimated Value 33
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter sensitivity
Estimated Value 73
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter specificity
Estimated Value 31
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter accuracy
Estimated Value 60
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter positive prediction
Estimated Value 96
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter negative prediction
Estimated Value 73
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter sensitivity
Estimated Value 87
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter specificity
Estimated Value 92
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter accuracy
Estimated Value 88
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98)
Hide Description PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined without malign lesions <=5mm.
Time Frame within < 2 weeks after PET/MRI
Hide Outcome Measure Data
Hide Analysis Population Description
lesion based (malignant lesions >5mm, n=98) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)
Arm/Group Title FEC-PET Magnetic Resonance Imaging (MRI) PET/MRI
Hide Arm/Group Description:
PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a "cold" transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure.
The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
Overall Number of Participants Analyzed 38 38 38
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
98 98 98
Measure Type: Number
Unit of Measure: lesions
True positive 48 37 48
False positive 24 26 8
True negative 18 16 32
False negative 8 19 10
Total true 66 53 80
Total false 32 45 18
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter positive prediction
Estimated Value 67
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter negative prediction
Estimated Value 69
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter sensitivity
Estimated Value 86
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter specificity
Estimated Value 43
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection FEC-PET
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter accuracy
Estimated Value 67
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter positive prediction
Estimated Value 59
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter negative prediction
Estimated Value 46
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter sensitivity
Estimated Value 66
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter specificity
Estimated Value 38
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Magnetic Resonance Imaging (MRI)
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter accuracy
Estimated Value 54
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter positive prediction
Estimated Value 86
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter negative prediction
Estimated Value 76
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter sensitivity
Estimated Value 83
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter specificity
Estimated Value 80
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection PET/MRI
Comments

Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)

Null hypothesis: patient distribution in contingency table is incidental.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter accuracy
Estimated Value 82
Estimation Comments [Not Specified]
Time Frame Enrollment of first patient: 18th. December, 2007 (before PET/MRI) Completion by last patient: 12th. January, 2011 (after surgery) During the whole period (3 years, 1 month) adverse event data were collected.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FEC-PET/eMRI
Hide Arm/Group Description The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
All-Cause Mortality
FEC-PET/eMRI
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FEC-PET/eMRI
Affected / at Risk (%)
Total   0/39 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FEC-PET/eMRI
Affected / at Risk (%)
Total   0/39 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Major Medical Corps Dr. Markus Hartenbach
Organization: German Federal Armed Forces Hospital, Ulm
Phone: 0049 731 1710 1851
Publications:
Robert-Koch-Institut (2010): Krebs in Deutschland 2005/2006 Häufigkeiten und Trends. A collaborative publication of the Robert-Koch-Institut and the Gesellschaft der epidemiologischen Krebsregister in Deutschland e.V. [Society for epidemiological cancer register], 7th edition, Berlin.
Börgermann C, Rübben H (2006): Früherkennung des Prostatakarzinoms [Early recognition of prostate carcinoma]. Dtsch Arztebl. 103: 2399-2406.
Deutsche Gesellschaft für Urologie (2009): Interdisziplinäre Leitlinie der Qualität S3 zur Früherkennung, Diagnose und Therapie der verschiedenen Stadien des Prostatakarzinoms [Interdisciplinary guideline for the early recognition, diagnosis and therapy of the various stages of prostate carcinoma]. Deutsche Gesellschaft für Urologie e. V. (ed.), p. 53 ff.
FDA (2011): FDA clears new system to perform simultaneous PET, MRI scans. Available on-line at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2011/ucm258700.htm
Gauthier S, Diksic M, Yamamoto L, Tyler J, Feindel WH (1985): Positron emission tomography with [11C]-choline in human subjects. Can J Neurol Sci 12: 214.
Responsible Party: Dr. Markus Hartenbach, German Federal Armed Forces
ClinicalTrials.gov Identifier: NCT00520546     History of Changes
Other Study ID Numbers: 12K3-S-140708
2006-003933-33 ( EudraCT Number )
First Submitted: August 23, 2007
First Posted: August 24, 2007
Results First Submitted: July 20, 2011
Results First Posted: June 20, 2012
Last Update Posted: June 20, 2012