Safety and Efficacy of Folatescan (Technetium TC 99M EC20) in Patients With Suspected Ovarian Carcinoma or Recurrent Endometrial 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 PATIENTS WITH SUSPECTED OVARIAN CARCINOMA OR RECURRENT ENDOMETRIAL CARCINOMA

The folate receptor is overexpressed in many types of cancer, including ovarian and endometrial cancer, and the level of folate receptor expression increases with the stage of the disease. Technetium Tc 99m EC20 (99mTc-EC20; FolateScan), a folate-targeted diagnostic radiopharmaceutical, is designed to bind to the folate receptor. Thus, FolateScan may provide an effective method to determine folate receptor-positive (FR+) target tumors, thereby assisting in the identification of those patients who may benefit from folate-targeted therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This phase 2, two-center, open-label, single-treatment group, within-patient-controlled study was conducted to:

  • Expand the safety database and gather data on the percentage of patients with known or suspected ovarian carcinoma or recurrent endometrial carcinoma who show increased uptake of FolateScan in tumors (primary objective).
  • Calculate the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared with immunohistochemical (IHC) staining (secondary objective).

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

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 ovarian carcinoma or recurrent endometrial carcinoma with at least one identifiable lesion > 1.5 cm as diagnosed 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.
    3. Subject has completed the follow-up phase of any previous study less than 30 days prior to enrollment in this study.
    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
Patients received 2 intravenous (IV) injections: 1 mg of folic acid (to reduce the uptake of FolateScan in normal tissues), followed 1 to 3 minutes later by 0.1 mg of EC20 labeled with 15 to 25 mCi of technetium-99m (99mTc) over 30 seconds in a total injection volume of 1 to 2 mL.2 Each injection was given as a slow IV push via a free-flowing indwelling IV catheter in an upper extremity vein (i.e., in the antecubital fossa).
Drug: Tc 99m EC20

Collaborators and Investigators

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

Sponsor

Endocyte

Investigators

  • Principal Investigator: Val J Lowe, MD, Mayo Clinic

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, 2003

Study Completion (Actual)

August 1, 2005

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

  • EC20.4

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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