Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Endocyte
Treatments:
Technetium Tc 99m-ethylenedicysteine
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.