A Multi-center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Suspected Metastatic Renal Cell Carcinoma
18 Years
N/A
Both
Metastatic Renal Cell Carcinoma
Trial Information
A Multi-center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Suspected Metastatic Renal Cell Carcinoma
The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted
diagnostic radiopharmaceutical 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.
Endocyte's folate-targeted delivery system was applied towards the targeting of a diagnostic
imaging agent (111In-DTPA-Folate) to ovarian cancer tumors. This proof-of-principle study
was designed to demonstrate the ability of folate to target drugs to
folate-receptor-positive (FR+) cancer tissue.
Inclusion Criteria:
- Subjects must meet the following eligibility requirements to be enrolled in the
study.
1. Subject must be 18 years of age or older.
2. Subject must have known or strongly suspected metastatic renal cell carcinoma
with at least one target lesion as identified by ultrasonography, MRI, or CT.
3. Subject must have good kidney function.
4. Subject must provide written informed consent prior to enrollment.
Exclusion Criteria:
- Subjects must be excluded if any of the following conditions are present:
1. Subject is pregnant or breastfeeding.
2. Subject is simultaneously participating in another investigational drug study,
excluding the follow-up phase.
3. Subject has received an investigational agent within 7 days prior to enrollment.
4. Subject is unable to tolerate conditions for radionuclide imaging.
5. Subject has been administered another radiopharmaceutical that would interfere
with the assessment of Technetium Tc 99m EC20.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Authority:
United States: Food and Drug Administration
Study ID:
EC20.3
NCT ID:
NCT01689662
Start Date:
August 2002
Completion Date:
July 2003
Related Keywords:
- Metastatic Renal Cell Carcinoma
- Metastatic Renal Cell Carcinoma
- Carcinoma
- Carcinoma, Renal Cell
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
