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

Phase 3

Completed

Brief Summary: This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses.

Detailed Description: A preoperative 124I-cG250 PET scan may distinguish between clear cell and non-clear cell renal carcinoma in patients with renal masses. Studies of imaging characteristics of 124I by a variety of PET cameras, quantification of tumor uptake of 124I-labeled antibody and correlation with biopsy measurement of tumor and normal tissue have met with encouraging results. As clear cell renal cancers are associated with an aggressive phenotype their a priori determination may help guide appropriate surgical/therapeutic management.

Recruitment & Eligibility

Inclusion Criteria

Subject is over 18 years of age.
Presence of a renal mass.
Scheduled for surgical resection of renal mass (partial or total nephrectomy, open or laparoscopic technique).
Expected survival of at least 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status < 2.
The following laboratory results should be within the following limits within the last 2 weeks prior to study day 1:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Serum bilirubin ≤ 2.0 mg/dL
- Aspartate aminotransaminase (AST) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Serum creatinine ≤ 2.0 mg/dL (calculated creatinine clearance >45 ml/min)
Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product. All females of childbearing potential must indicate intent to avoid pregnancy and must use an accepted, effective method of contraception for the duration of the study.
Recovered from toxicity of any prior therapy.
Able and willing to give valid written informed consent.

Exclusion Criteria

Metastasis of primary tumor other than Renal Cell Carcinoma (RCC).
Prior history of malignancy within the last 5 years.
Prior exposure to murine proteins or chimeric antibodies.
Intercurrent medical condition that may limit the amount of antibody to be administered.
Intercurrent medical condition that renders the patient ineligible for surgery.
New York Heart Association Class III/IV cardiac disease.
History of autoimmune hepatitis.
Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to 124I-cG250 infusion on day 1.
Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
Lack of availability for immunological and clinical follow-up assessments.
Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrolment.
Women who are pregnant or breastfeeding.
Allergy to iodine, hyperthyroidism, or Grave's Disease.
Known allergic reaction to human serum albumin.
Contraindication for contrast-enhanced CT or PET/CT.
Contraindication to potassium iodide intake (see package insert).

Arm && Interventions

Group	Intervention	Description
124-Iodine-cG250 (124I-cG250)	124-Iodine-cG250 (124I-cG250)	Single arm study, comparing 124I cG250 PET/CT and CT. Each patient underwent a PET/CT and CT scan days (+/-2days) after receipt of 124I cG250.
124-Iodine-cG250 (124I-cG250)	CT	Single arm study, comparing 124I cG250 PET/CT and CT. Each patient underwent a PET/CT and CT scan days (+/-2days) after receipt of 124I cG250.

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of 124I-cG250 PET/CT Versus Diagnostic CT.	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging	6 months	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.
Positive Predictive Value (PPV)	6 months	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.
Negative Predictive Value (NPV)	6 months	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.

Locations (14): Ohio State University
🇺🇸
Columbus, Ohio, United States
David Geffen School of Medicine, UCLA
🇺🇸
Los Angeles, California, United States
Fox Chase Cancer Center
🇺🇸
Philadelphia, Pennsylvania, United States
Lahey Clinic
🇺🇸
Burlington, Massachusetts, United States
Stanford University Medical Center
🇺🇸
Stanford, California, United States
H. Lee Moffitt Cancer Center & Research Center
🇺🇸
Tampa, Florida, United States
Nevada Cancer Institute
🇺🇸
Las Vegas, Nevada, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸
New York, New York, United States
UNC School of Medicine-Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
MD Anderson
🇺🇸
Houston, Texas, United States