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

NCT01686256 | Completed Phase 1

• 1 other identifier: EC20.2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Endometrial Cancer

Keywords

Ovarian Cancer; Endometrial Cancer

Study Arms (1)

Tc 99m EC20

EXPERIMENTAL

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.

Drug: Tc 99m EC20

Interventions

Tc 99m EC20 DRUG

Each subject will receive 1 mg of folic acid injected 1-3 minutes prior to administration of Technetium Tc 99m EC20.

Tc 99m EC20

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Endocyte: lead

Study Sites (1)

Indiana University Medical Center

Indianapolis, Indiana, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Study Officials

• James W. Fletcher, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2012
• First Posted: September 18, 2012
• Study Start: August 1, 2001
• Primary Completion: August 1, 2004
• Last Updated: June 22, 2023

Record last verified: 2012-09

Locations

US (1)