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

Completed · Phase 1

Conditions studied: Ovarian Cancer, Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT01686256

Run by

Endocyte

People needed

12

Starts

2001-08-01

Last updated by the study team

2023-06-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet the following eligibility requirements to be enrolled in the study.
• Subjects must be female, 18 years of age or older.
• 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.
• 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.
• Subjects must provide written informed consent prior to enrollment.
• Subjects must have kidney function with a creatinine value <2.0 mg/dL (within the previous 30 days).

You may not qualify if…

• Subjects must be excluded if any of the following conditions are present:
• Subject is pregnant or breast-feeding.
• Subject is simultaneously participating in another investigative drug study.
• Subject has completed the follow-up phase of any previous study less than 30 days prior to enrollment in this study.
• Subject is unable to tolerate conditions for radionuclide imaging.
• Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.

Where it is running

• Indiana University Medical Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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