Know Cancer

or
forgot password

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 1
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Endometrial Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Principal Investigator

James W. Fletcher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Food and Drug Administration

Study ID:

EC20.2

NCT ID:

NCT01686256

Start Date:

August 2001

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Endometrial Cancer
  • Ovarian Cancer
  • Endometrial Cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Ovarian Neoplasms
  • Adenoma

Name

Location

Indiana University Medical CenterIndianapolis, Indiana  46202