A Screening Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma

Fecha de inicio: 1 de noviembre de 2003

Inclusion Criteria: To be eligible for the study, patients must fulfill all of the following criteria: Patient must be 18 years of age or older. Patient must have suspected metastatic renal cell carcinoma with at least one identifiable lesion >2.0 cm as diagnosed by CT, MRI, or ultrasonography within 60 days prior to enrollment. Patient must have good kidney function defined as a serum creatinine ≤1.5 X ULN. Patient must provide written informed consent prior to enrollment. Patients must provide a formalin-fixed, paraffin-embedded tissue sample of either the primary or metastatic or recurrent site(s) for IHC staining for the presence of folate receptors from either a previous surgical/biopsy procedure or from a surgery/biopsy scheduled within 30 days of FolateScan. A fine needle aspirate is not acceptable. Exclusion Criteria: Any of the following criteria will make the patient ineligible to participate in this study: Patient is pregnant or breastfeeding. Patient is simultaneously participating in another investigational drug study, excluding the follow-up phase. Patient has received an investigational agent or therapeutic chemotherapy within 7 days prior to enrollment. Patient is unable to tolerate conditions for radionuclide imaging. Patient has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.