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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2, multi-center, open-label, single-treatment group, baseline-controlled study to identify subjects with Folate Receptor-Positive Metastatic Renal Cell Carcinoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endocyte
• Treatments: Technetium Tc 99m-ethylenedicysteine

Criteria

Inclusion Criteria:

• To be eligible for the study, patients must fulfill all of the following criteria:

1. Patient must be 18 years of age or older.

2. 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.

3. Patient must have good kidney function defined as a serum creatinine ≤1.5 X ULN.

4. Patient must provide written informed consent prior to enrollment.

5. 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:

1. Patient is pregnant or breastfeeding.

2. Patient is simultaneously participating in another investigational drug study, excluding the follow-up phase.

3. Patient has received an investigational agent or therapeutic chemotherapy within 7 days prior to enrollment.

4. Patient is unable to tolerate conditions for radionuclide imaging.

5. Patient has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.