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

July 24, 2023 updated by: Endocyte

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

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

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 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).

Study Type

Interventional

Enrollment (Actual)

150

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
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • 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:

  • 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.

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
Other: Technetium Tc 99m EC20
Drug: Technetium 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

November 1, 2003

Primary Completion (Actual)

November 1, 2007

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)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC20.9

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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