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Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody

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ClinicalTrials.gov Identifier: NCT00606632
Recruitment Status : Completed
First Posted : February 4, 2008
Results First Posted : April 14, 2014
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Heidelberg Pharma AG

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Renal Cell Carcinoma
Kidney Cancer
Interventions Drug: 124-Iodine-cG250 (124I-cG250)
Procedure: CT
Enrollment 226
Recruitment Details 226 subjects were enrolled at 14 study sites in the USA.
Pre-assignment Details  
Arm/Group Title PET/CT Versus CT
Hide Arm/Group Description PET/CT and CT scans for all study subjects 4 days (+/- 2 days) after 124I cG250 administration.
Period Title: Overall Study
Started 226
Completed 204
Not Completed 22
Reason Not Completed
Withdrawal by Subject             13
Miscellaneous reasons             9
Arm/Group Title PET/CT Versus CT
Hide Arm/Group Description All subjects were scheduled to receive a PET/CT and a diagnostic CT
Overall Number of Baseline Participants 226
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants
<=18 years
0
   0.0%
Between 18 and 65 years
167
  73.9%
>=65 years
59
  26.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 226 participants
56.1  (12.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants
Female
84
  37.2%
Male
142
  62.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 226 participants
226
1.Primary Outcome
Title Sensitivity and Specificity of 124I-cG250 PET/CT Versus Diagnostic CT.
Hide Description

Average estimate of three independent, blinded central readers per imaging modality on the proportion of participants that were correctly identified on the 124I-cG250 PET/CT Images of having (sensitivity) or not having (specificity) clear cell renal carcinoma (ccRCC) compared to CT images.

Histopathology provided the standard-of-truth because it is the only definitive method for accurately identifying ccRCC.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITD (Intend-to-Diagnose) observed case: All subjects who were enrolled and infused with the investigational product and who had a "standard-of-truth" (histopathology) result and images evaluated as readable by the blinded readers
Arm/Group Title Sensitivity CT Sensitivity PET/CT Specificity PET/CT Specificity CT
Hide Arm/Group Description:

Sensitivity of diagnostic CT scan for proportion of patients with positive histology (ccRCC) and evaluable images.

The sensitivity refers to the ability of the diagnostic test to correctly identify those patients with the disease, in this case ccRCC.

Sensitivity of 124I-cG250 PET/CT scan for proportion of patients with positive histology (ccRCC) and evaluable images.

The sensitivity refers to the ability of the diagnostic test to correctly identify those patients with the disease, in this case ccRCC.

Specificity of 124I-cG250 PET/CT scan for proportion of patients with negative histology (no ccRCC) and evaluable images.

The specificity of refers to the ability of the diagnostic test to correctly identify those patients without the disease (in this case non-ccRCC).

Specificity of CT scan for proportion of patients with negative histology (no ccRCC) and evaluable images.

The specificity refers to the ability of the diagnostic test to correctly identify those patients without the disease (in this case non-ccRCC).

Overall Number of Participants Analyzed 143 143 52 52
Mean (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.76
(0.63 to 0.88)
0.86
(0.75 to 0.97)
0.86
(0.69 to 1.0)
0.47
(0.19 to 0.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sensitivity CT, Sensitivity PET/CT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Specificity PET/CT, Specificity CT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
2.Secondary Outcome
Title Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging
Hide Description The Accuracy is the proportion of participants with correct determinations of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITD (Intend-to-Diagnose) observed case: All subjects who were enrolled and infused with the investigational product and who had a "standard-of-truth" (histopathology) result and images evaluated as readable by the blinded readers
Arm/Group Title PET/CT Diagnostic CT
Hide Arm/Group Description:
Patients with 124I-cG250 PET/CT evaluable images.
Patients with diagnostic CT images.
Overall Number of Participants Analyzed 195 195
Measure Type: Number
Unit of Measure: Proportion of participants
0.86 0.68
3.Secondary Outcome
Title Positive Predictive Value (PPV)
Hide Description The Positive Predictive Value (PPV) reflects the Proportion of positive results that are true positive. The PPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITD (Intend-to-Diagnose) observed case: All subjects who were enrolled and infused with the investigational product and who had a "standard-of-truth" (histopathology) result and images evaluated as readable by the blinded readers
Arm/Group Title PET/CT Diagnostic CT
Hide Arm/Group Description:
Patients with 124I-cG250 PET/CT evaluable images.
Patients with diagnostic CT images.
Overall Number of Participants Analyzed 195 195
Measure Type: Number
Unit of Measure: Protportion of participants
0.94 0.80
4.Secondary Outcome
Title Negative Predictive Value (NPV)
Hide Description Negative Predictive Value (NPV) reflects the proportion of negative results that are true negatives. The NPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITD (Intend-to-Diagnose) observed case: All subjects who were enrolled and infused with the investigational product and who had a "standard-of-truth" (histopathology) result and images evaluated as readable by the blinded readers
Arm/Group Title PET/CT Diagnostic CT
Hide Arm/Group Description:
Patients with 124I-cG250 PET/CT evaluable images.
Patients with diagnostic CT images.
Overall Number of Participants Analyzed 195 195
Measure Type: Number
Unit of Measure: Proportion of participants
0.69 0.41
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PET/CT Versus CT
Hide Arm/Group Description All subjects were scheduled to receive a PET/CT and a diagnostic CT
All-Cause Mortality
PET/CT Versus CT
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
PET/CT Versus CT
Affected / at Risk (%) # Events
Total   33/226 (14.60%)    
Cardiac disorders   
Cardiac Arrest   1/226 (0.44%)  1
Cardiac failure   1/226 (0.44%)  1
Gastrointestinal disorders   
Nausea   1/226 (0.44%)  1
Constipation   1/226 (0.44%)  1
Abdominal pain   2/226 (0.88%)  2
Vomiting   1/226 (0.44%)  1
Colitis   1/226 (0.44%)  1
Gastrointestinal haemorrhage   1/226 (0.44%)  1
Intestinal perforation   1/226 (0.44%)  1
Retroperitoneal haemorrhage   1/226 (0.44%)  1
General disorders   
Disease Progression   1/226 (0.44%)  1
Infections and infestations   
Clostridial infection   1/226 (0.44%)  1
Pyelonephritis   1/226 (0.44%)  1
Sepsis   1/226 (0.44%)  1
Injury, poisoning and procedural complications   
Urinary anastomotic leak   3/226 (1.33%)  3
Investigations   
Hepatic enzyme increased   1/226 (0.44%)  1
Musculoskeletal and connective tissue disorders   
Flank pain   1/226 (0.44%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Glioma   1/226 (0.44%)  1
Nervous system disorders   
Cerebral infarction   1/226 (0.44%)  1
Renal and urinary disorders   
Haematuria   2/226 (0.88%)  2
Extravasation of urine   1/226 (0.44%)  1
Nephrolithiasis   1/226 (0.44%)  1
Renal haemorrhage   1/226 (0.44%)  1
Renal infarct   1/226 (0.44%)  1
Urinary tract obstruction   1/226 (0.44%)  1
Urinoma   1/226 (0.44%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion   3/226 (1.33%)  3
Dyspnoea   2/226 (0.88%)  2
Pulmonary embolism   3/226 (1.33%)  3
Respiratory failure   1/226 (0.44%)  1
Vascular disorders   
Hypotension   1/226 (0.44%)  1
Haematoma   3/226 (1.33%)  3
Deep vein thrombosis   1/226 (0.44%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PET/CT Versus CT
Affected / at Risk (%) # Events
Total   191/226 (84.51%)    
Gastrointestinal disorders   
Nausea   44/226 (19.47%)  44
Constipation   26/226 (11.50%)  26
Abdominal pain   25/226 (11.06%)  25
Diarrhoea   19/226 (8.41%)  19
Vomitting   13/226 (5.75%)  13
General disorders   
Fatigue   26/226 (11.50%)  26
Pain   12/226 (5.31%)  12
Injury, poisoning and procedural complications   
Procedural pain   27/226 (11.95%)  27
Incision site pain   19/226 (8.41%)  19
Musculoskeletal and connective tissue disorders   
Back pain   15/226 (6.64%)  15
Nervous system disorders   
Headache   24/226 (10.62%)  24
Dizziness   14/226 (6.19%)  14
Dysgeusia   12/226 (5.31%)  12
Psychiatric disorders   
Insomnia   19/226 (8.41%)  19
Anxiety   14/226 (6.19%)  14
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of R&D
Organization: Heidelberg Pharma AG (former Wilex AG)
EMail: info@hdpharma.com
Layout table for additonal information
Responsible Party: Heidelberg Pharma AG
ClinicalTrials.gov Identifier: NCT00606632    
Other Study ID Numbers: WX/20-001
First Submitted: January 21, 2008
First Posted: February 4, 2008
Results First Submitted: June 7, 2011
Results First Posted: April 14, 2014
Last Update Posted: October 2, 2018