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Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endocyte
ClinicalTrials.gov Identifier:
NCT01686256
First received: September 9, 2012
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  Purpose

A Multi-Center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women with Suspected Ovarian or Endometrial Cancer.

Phase I - The proposed indication for FolateScan is disease or pathological assessment of ovarian or endometrial masses.


Condition Intervention Phase
Ovarian Cancer
Endometrial Cancer
 Drug: Tc 99m EC20
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Multi-center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Endocyte:

Enrollment: 12
Study Start Date: August 2001
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tc 99m EC20
A Phase 1, multi-center, open-label, single-treatment group, baseline-controlled (for safety) study designed to verify product safety, determine optimal imaging time, gather efficacy data for the radioactive drug product (Technetium Tc 99m EC20), and assay masses for presence of folate receptors, in women with suspected ovarian or endometrial cancer. Twelve subjects will be enrolled, with a minimum of five malignant cases, as determined by histopathological evaluation.
 Drug: Tc 99m EC20
Each subject will receive 1 mg of folic acid injected 1-3 minutes prior to administration of Technetium Tc 99m EC20.

Detailed Description:

The study is designed to verify product safety, determine optimal imaging time, gather efficacy data for the radioactive drug product (Technetium Tc 99m EC20), and assay masses for presence of folate receptors, in women with suspected ovarian or endometrial cancer. Twelve subjects will be enrolled, with a minimum of five malignant cases, as determined by histopathological evaluation.

Women with a suspected ovarian or endometrial mass who either 1) have fixed, paraffin embedded tissue sample(s) available for immunohistochemical staining obtained from a previous pathological evaluation or 2) are scheduled for a procedure to obtain tissue for pathological evaluation that can be fixed and paraffin embedded for immunohistochemical staining are eligible for this study. The ovarian mass may be either an initial finding, e.g., found at a routine pelvic examination or to investigate symptoms, or the ovarian or endometrial mass may be a finding suspicious of recurrent or residual tumor at follow-up examination after surgical resection of confirmed ovarian or endometrial cancer. Patients may not be pregnant or breastfeeding at enrollment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must meet the following eligibility requirements to be enrolled in the study.

    1. Subjects must be female, 18 years of age or older.
    2. Subjects must have suspected ovarian cancer or metastatic or recurrent ovarian or endometrial cancer with a known pelvic mass as diagnosed by ultrasound, MRI, or CT.
    3. Subjects either are scheduled to undergo a procedure to obtain tissue for pathological evaluation that can be fixed and paraffin embedded for immunohistochemical staining or have sufficient amounts of fixed, paraffin embedded tissue sample(s) available for immunohistochemical staining obtained from a previous pathological evaluation.
    4. Subjects must provide written informed consent prior to enrollment.
    5. Subjects must have kidney function with a creatinine value <2.0 mg/dL (within the previous 30 days).

Exclusion Criteria:

  • Subjects must be excluded if any of the following conditions are present:

    1. Subject is pregnant or breast-feeding.
    2. Subject is simultaneously participating in another investigative 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686256

Locations
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States
Sponsors and Collaborators
Endocyte
Investigators
Principal Investigator: James W. Fletcher, MD Indiana University
  More Information

No publications provided

Responsible Party: Endocyte
ClinicalTrials.gov Identifier: NCT01686256     History of Changes
Other Study ID Numbers: EC20.2
Study First Received: September 9, 2012
Last Updated: September 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Endocyte:
Ovarian Cancer
Endometrial Cancer

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Ovarian Neoplasms
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
 Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 23, 2013