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

Phase 2
18 Years
Not Enrolling
Metastatic Renal Cell Carcinoma

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Trial Information

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

The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted
diagnostic radiopharmaceutical agent designed to bind to the folate receptor. The folate
receptor is a glycoprotein that is over-expressed in many types of cancer cells but it is
only minimally distributed in normal tissues . Folate conjugates bind to the folate receptor
with high affinity and are brought into the cell via endocytosis. In contrast, folic acid
itself enters most normal cells via the reduced folate carrier, a pathway entirely
inaccessible to folate conjugates. Therefore, these folate conjugates are specific to
cancer cells.

This is a phase 2, multi-center, open-label, single-treatment group, baseline-controlled
study designed to verify product safety, gather data on the percentage of metastatic renal
cell carcinoma patients with increased uptake of FolateScan in tumors, and to calculate
sensitivity, specificity, accuracy, positive predictive value, and negative predictive value
of FolateScan compared to immunohistochemical staining (IHC).

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label


United States: Food and Drug Administration

Study ID:




Start Date:

November 2003

Completion Date:

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Renal Cell
  • Carcinoma
  • Carcinoma, Renal Cell



Baylor College of Medicine Houston, Texas  77030
Mayo Clinic Rochester, Minnesota  55905