Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal M… (NCT00199888) | Clinical Trial Compass
CompletedPhase 1
Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.
United States26 participantsStarted 2005-06
Plain-language summary
The purpose of this study is to see if an antibody (cG250) attached to a radioactive substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled for surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Presence of a renal mass.
✓. Scheduled for surgical resection of renal mass.
✓. Expected survival of at least 3 months.
✓. Karnofsky performance scale ≥70.
✓. The following laboratory results should be within the following limits within the last 4 weeks prior to study day 1:
✓. Pregnancy Test to be performed on female patients of childbearing potential within 24-48 hours before administration of radioactive material.
✓. Recovered from toxicity of any prior therapy.
✓. Able and willing to give valid written informed consent.
Exclusion criteria
✕. 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 the first cG250 dose.
✕
What they're measuring
1
Positive Predictive Value (PPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.