Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Suspected Metastatic Renal Cell Carcinoma

June 20, 2023 updated by: Endocyte

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 folate receptor (FR) is overexpressed by many different cancer types, including renal cell carcinoma. Besides helping in the diagnosis of cancer, a folate-targeted imaging agent could provide an effective method to identify folate receptor-positive (FR+) cancer patients that may benefit from folate-targeted therapy. Up to 40 subjects, with known or strongly suspected metastatic renal cell carcinoma with at least one target lesion detected by a diagnostic imaging procedure (e.g. ultrasonography, CT, or MRI), will be enrolled in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tc 99m EC20

Subjects will receive two intravenous injections 1-3 minutes apart:

  1. 1 mg of folic acid
  2. 1-2 mL injection of 0.1 mg of EC20 labeled with 15-25 mCi of technetium-99m
Drug: Tc 99m EC20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endocyte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Study Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

September 9, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimated)

September 21, 2012

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC20.3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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