A Comparative Study of PET/CT Versus Diagnostic CT for the Detection of Clear Cell Renal Cell Carcinoma in Pre-surgical Patients With Renal Masses Using Iodine-124 Labeled Chimeric G250 (124I-cG250)
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : 124-Iodine-cG250 (124I-cG250)
- procedure : CT
Phase: Phase 3
Ages Eligible For Study:
- 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.