Conditions: Renal Cell Carcinoma Kidney Cancer
Keywords: Renal Mass Clear Cell Renal Cell Carcinoma Cancer of Kidney Kidney Cancer Neoplasms cG250 antibody, monoclonal Iodine 124 Positron-Emission Tomography Kidney Renal Cancer Renal Neoplasms
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 226
Healthy volunteers: no

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.

Arms:
arm 1: 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.

Interventions: intervention 1: 124-Iodine-cG250 (124I-cG250) intervention 2: CT
Intervention descriptions: intervention 1: i.v. and PET/CT scan 4+/-2 days after administration intervention 2: contrast enhanced CT scan

Protocol document: