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Trial record 95 of 95 for:    gadobenate dimeglumine

Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02501759
Recruitment Status : Terminated (Low enrollment and funding loss.)
First Posted : July 17, 2015
Results First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
Medical Research Foundation, Oregon
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fergus Coakley, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Health Status Unknown
Prostate Carcinoma
Interventions Procedure: 3 Tesla Magnetic Resonance Imaging
Radiation: Gadodiamide
Procedure: Multiparametric Magnetic Resonance Imaging
Procedure: Transrectal Biopsy
Procedure: Ultrasound-Guided Prostate Biopsy
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)
Hide Arm/Group Description

Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.

3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Gadodiamide: Given IV

Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Transrectal Biopsy: Undergo transrectal MRI-guided biopsy

Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy

Period Title: Overall Study
Started 2
Completed 1
Not Completed 1
Arm/Group Title Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)
Hide Arm/Group Description

Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.

3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Gadodiamide: Given IV

Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Transrectal Biopsy: Undergo transrectal MRI-guided biopsy

Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  50.0%
>=65 years
1
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Proportion of MRI-guided Biopsies That Demonstrate a Higher Gleason Score Than Contemporaneous TRUS Guided Biopsy
Hide Description The proportion of MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous TRUS guided biopsy for all patients diagnosed of prostate cancer based on the reference standard will be estimated. McNemar’s test will be used to assess whether the MRI-guided biopsies are more likely to yield a higher Gleason score compared with TRUS guided biopsy. Simple logistic regression model will be used to assess the association between the higher Gleason score and patient characteristics and/or clinical information for patients diagnosed of prostate cancer.
Time Frame Up to 42 days (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, insufficient data was collected to report this outcome
Arm/Group Title Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)
Hide Arm/Group Description:

Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.

3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Gadodiamide: Given IV

Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Transrectal Biopsy: Undergo transrectal MRI-guided biopsy

Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Sensitivity of MRI-guided Biopsy
Hide Description The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar’s test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.
Time Frame Up to 2 weeks after diagnostic MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, insufficient data was collected to report this outcome
Arm/Group Title Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)
Hide Arm/Group Description:

Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.

3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Gadodiamide: Given IV

Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Transrectal Biopsy: Undergo transrectal MRI-guided biopsy

Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Sensitivity of TRUS-guided Biopsy
Hide Description The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar’s test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.
Time Frame Up to 2 weeks after MRI-guided biopsy
Hide Outcome Measure Data
Hide Analysis Population Description
Due to low enrollment, insufficient data was collected to report this outcome
Arm/Group Title Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)
Hide Arm/Group Description:

Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.

3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Gadodiamide: Given IV

Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Transrectal Biopsy: Undergo transrectal MRI-guided biopsy

Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)
Hide Arm/Group Description

Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.

3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Gadodiamide: Given IV

Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Transrectal Biopsy: Undergo transrectal MRI-guided biopsy

Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy

All-Cause Mortality
Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Since recruitment was very low and funding did not materialize, the study was closed early and insufficient data was collected to analyze and report the outcomes.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Fegus Coakley
Organization: OHSU Knight Cancer Institute
Phone: 503-494-2333
EMail: coakleyf@ohsu.edu
Layout table for additonal information
Responsible Party: Fergus Coakley, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT02501759     History of Changes
Other Study ID Numbers: IRB00010086
NCI-2015-00930 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SOL-13142-LM
IRB00010086 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Submitted: July 15, 2015
First Posted: July 17, 2015
Results First Submitted: March 11, 2019
Results First Posted: April 3, 2019
Last Update Posted: April 3, 2019