Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients

June 20, 2023 updated by: Endocyte

CLINICAL STUDY OF A SINGLE-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND BIODISTRIBUTION OF TECHNETIUM Tc 99m EC20 IN NORMAL VOLUNTEERS AND OVARIAN CANCER PATIENTS

Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four subjects with known or suspected ovarian cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a single-center, open-label evaluation of a single injection of Tc 99m EC20 containing 0.1 mg EC20 labeled with 15 - 20 mCi of technetium-99m in normal volunteers and patients with known or suspected ovarian cancer. Two normal volunteers and two patients also were to receive an injection of 0.25 - 2.0 mg folic acid 1 to 2 minutes prior to the injection of Tc 99m EC20. Serial blood samples and urine were collected during the 24-hour period following each injection for pharmacokinetic evaluation. Serial whole body images were acquired during the 24-hour postdose period for dosimetry evaluations. Safety was monitored through predose and postdose physical examinations, electrocardiograms (ECGs), vital signs and clinical laboratory evaluations. Adverse events were monitored from the time of signing of Informed Consent to 24 hours postdose.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

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
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington University Medical Center

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

Yes

Description

Inclusion Criteria:

  • All subjects were to be females 18 years of age or older who met the following criteria:

    1. The four normal subjects were to be normal, as established by medical history, physical examination, and laboratory data, including CBC, serum chemistry, and urinalysis.
    2. The two subjects with obvious advanced stage ovarian cancer were to have either histopathologically proven stage 3 or 4 disease or clinically obvious disease defined by 2 of the following 3 conditions: (1) pelvic mass (2) omental "caking", or (3) ascites.
    3. Subjects were to have newly diagnosed, treatment refractory, or recurrent disease. Subjects were to be treatment naïve or at least 2 months since last non-surgical treatment. Subjects were to have normal kidney and liver function.
    4. The two subjects with suspected ovarian cancer were to have a known mass. Subjects were to have normal kidney and liver function.
    5. Subjects were to provide informed consent prior to enrollment.

Exclusion Criteria:

  • The following subjects were to be excluded:

    1. Subject was pregnant or breast-feeding.
    2. Subject was simultaneously participating in another investigative drug or device study, or had completed follow-up phase of any previous study within 30 days prior to enrollment in this study.
    3. Subject had a known history of chronic abuse of drugs or alcohol or had tested positive in the pre-study urine drug abuse screen.
    4. Subject was currently taking folic acid supplements and could not stop taking the supplements for a period of 3 days (2 days prior to the study and one day after last imaging procedure).
    5. Subject had physical condition that was unsuitable for radionuclide imaging.
    6. Subject had been administered another radiopharmaceutical that would interfere with the assessment of the biodistribution 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: Single-center, open-label

The study was designed as a single-center, open-label clinical study to evaluate the safety, pharmacokinetics, dosimetry and metabolism of Tc 99m EC20 in normal volunteers and in patients with known or suspected ovarian cancer.

Eight subjects were to be enrolled at one center: four normal subjects, four patients with ovarian cancer. Each subject was to receive a single injection of Tc 99m EC20 complex composed of 0.1 mg ligand (EC20) and 15 - 20 mCi of Tc 99m. Two (2) of the 4 normal subjects and 2 of the 4 patients were to receive an injection of 0.25-2.0 mg folic acid 1-2 minutes prior to the injection of Tc 99m EC20.
Drug: Tc 99m EC20

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the biodistribution and excretion of the radioactive drug substance (Technetium Tc 99m EC20) and estimate the radiation absorbed dose
Time Frame: 24 hours
24 hours

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, 2000

Study Completion (Actual)

July 1, 2002

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

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC20.1

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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