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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

September 9, 2012
September 12, 2012
August 2001
August 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01686256 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer
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

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Ovarian Cancer
  • Endometrial Cancer
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.
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.
Intervention: Drug: Tc 99m EC20
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
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August 2004   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01686256
EC20.2
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Endocyte
Endocyte
Not Provided
Principal Investigator: James W. Fletcher, MD Indiana University
Endocyte
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP