Trial Outcomes & Findings for Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody (NCT NCT00606632)
NCT ID: NCT00606632
Last Updated: 2018-10-02
Results Overview
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.
COMPLETED
PHASE3
226 participants
6 months
2018-10-02
Participant Flow
226 subjects were enrolled at 14 study sites in the USA.
Participant milestones
| Measure |
PET/CT Versus CT
PET/CT and CT scans for all study subjects 4 days (+/- 2 days) after 124I cG250 administration.
|
|---|---|
|
Overall Study
STARTED
|
226
|
|
Overall Study
COMPLETED
|
204
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
PET/CT Versus CT
PET/CT and CT scans for all study subjects 4 days (+/- 2 days) after 124I cG250 administration.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Miscellaneous reasons
|
9
|
Baseline Characteristics
Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody
Baseline characteristics by cohort
| Measure |
PET/CT Versus CT
n=226 Participants
All subjects were scheduled to receive a PET/CT and a diagnostic CT
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
167 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
59 Participants
n=5 Participants
|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 12.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
226 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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
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.
Outcome measures
| Measure |
Sensitivity CT
n=143 Participants
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 PET/CT
n=143 Participants
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 PET/CT
n=52 Participants
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 CT
n=52 Participants
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).
|
|---|---|---|---|---|
|
Sensitivity and Specificity of 124I-cG250 PET/CT Versus Diagnostic CT.
|
0.76 Proportion of participants
Interval 0.63 to 0.88
|
0.86 Proportion of participants
Interval 0.75 to 0.97
|
0.86 Proportion of participants
Interval 0.69 to 1.0
|
0.47 Proportion of participants
Interval 0.19 to 0.75
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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
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.
Outcome measures
| Measure |
Sensitivity CT
n=195 Participants
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 PET/CT
n=195 Participants
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 PET/CT
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 CT
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).
|
|---|---|---|---|---|
|
Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging
|
0.86 Proportion of participants
|
0.68 Proportion of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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
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.
Outcome measures
| Measure |
Sensitivity CT
n=195 Participants
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 PET/CT
n=195 Participants
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 PET/CT
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 CT
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).
|
|---|---|---|---|---|
|
Positive Predictive Value (PPV)
|
0.94 Protportion of participants
|
0.80 Protportion of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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
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.
Outcome measures
| Measure |
Sensitivity CT
n=195 Participants
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 PET/CT
n=195 Participants
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 PET/CT
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 CT
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).
|
|---|---|---|---|---|
|
Negative Predictive Value (NPV)
|
0.69 Proportion of participants
|
0.41 Proportion of participants
|
—
|
—
|
Adverse Events
PET/CT Versus CT
Serious adverse events
| Measure |
PET/CT Versus CT
n=226 participants at risk
All subjects were scheduled to receive a PET/CT and a diagnostic CT
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
0.44%
1/226 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.44%
1/226 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.88%
2/226 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.44%
1/226 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.44%
1/226 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.44%
1/226 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.44%
1/226 • Number of events 1
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.44%
1/226 • Number of events 1
|
|
Nervous system disorders
Cerebral infarction
|
0.44%
1/226 • Number of events 1
|
|
General disorders
Disease Progression
|
0.44%
1/226 • Number of events 1
|
|
Injury, poisoning and procedural complications
Urinary anastomotic leak
|
1.3%
3/226 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
3/226 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.88%
2/226 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
3/226 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.44%
1/226 • Number of events 1
|
|
Infections and infestations
Clostridial infection
|
0.44%
1/226 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
0.44%
1/226 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.44%
1/226 • Number of events 1
|
|
Investigations
Hepatic enzyme increased
|
0.44%
1/226 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.88%
2/226 • Number of events 2
|
|
Renal and urinary disorders
Extravasation of urine
|
0.44%
1/226 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.44%
1/226 • Number of events 1
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.44%
1/226 • Number of events 1
|
|
Renal and urinary disorders
Renal infarct
|
0.44%
1/226 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.44%
1/226 • Number of events 1
|
|
Renal and urinary disorders
Urinoma
|
0.44%
1/226 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.44%
1/226 • Number of events 1
|
|
Vascular disorders
Haematoma
|
1.3%
3/226 • Number of events 3
|
|
Vascular disorders
Deep vein thrombosis
|
0.44%
1/226 • Number of events 1
|
|
Cardiac disorders
Cardiac Arrest
|
0.44%
1/226 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.44%
1/226 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.44%
1/226 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.44%
1/226 • Number of events 1
|
Other adverse events
| Measure |
PET/CT Versus CT
n=226 participants at risk
All subjects were scheduled to receive a PET/CT and a diagnostic CT
|
|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
11.9%
27/226 • Number of events 27
|
|
Gastrointestinal disorders
Nausea
|
19.5%
44/226 • Number of events 44
|
|
Gastrointestinal disorders
Constipation
|
11.5%
26/226 • Number of events 26
|
|
General disorders
Fatigue
|
11.5%
26/226 • Number of events 26
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
25/226 • Number of events 25
|
|
Nervous system disorders
Headache
|
10.6%
24/226 • Number of events 24
|
|
Gastrointestinal disorders
Diarrhoea
|
8.4%
19/226 • Number of events 19
|
|
Injury, poisoning and procedural complications
Incision site pain
|
8.4%
19/226 • Number of events 19
|
|
Psychiatric disorders
Insomnia
|
8.4%
19/226 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.6%
15/226 • Number of events 15
|
|
Psychiatric disorders
Anxiety
|
6.2%
14/226 • Number of events 14
|
|
Nervous system disorders
Dizziness
|
6.2%
14/226 • Number of events 14
|
|
Gastrointestinal disorders
Vomitting
|
5.8%
13/226 • Number of events 13
|
|
Nervous system disorders
Dysgeusia
|
5.3%
12/226 • Number of events 12
|
|
General disorders
Pain
|
5.3%
12/226 • Number of events 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60