Clinical Trial · NCT01686256

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

Overview

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.

Sponsor

Endocyte

Phase

Phase 1

Contacts

James W. Fletcher, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01686256

Drug / Compound

EC20

Isotope(s):

Target(s):

FR (Folate Receptor)

Ligand Class: Small Molecules

Eligibility

Inclusion

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 must provide written informed consent prior to enrollment.
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 meet the following eligibility requirements to be enrolled in the study.

Exclusion

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.
* Subjects must be excluded if any of the following conditions are present:
Subject is unable to tolerate conditions for radionuclide imaging.