Safety and Efficacy of Folatescan (Technetium TC 99M EC20) in Patients With Suspected Ovarian Carcinoma or Recurrent Endometrial Carcinoma

NCT01689714 | Completed Phase 2 DMC

• 1 other identifier: EC20.4
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The folate receptor is overexpressed in many types of cancer, including ovarian and endometrial cancer, and the level of folate receptor expression increases with the stage of the disease. Technetium Tc 99m EC20 (99mTc-EC20; FolateScan), a folate-targeted diagnostic radiopharmaceutical, is designed to bind to the folate receptor. Thus, FolateScan may provide an effective method to determine folate receptor-positive (FR+) target tumors, thereby assisting in the identification of those patients who may benefit from folate-targeted therapy.

Conditions

Ovarian Carcinoma; Recurrent Endometrial Carcinoma

Keywords

Ovarian Carcinoma; Recurrent Endometrial Carcinoma

Study Arms (1)

Tc 99m EC20

EXPERIMENTAL

Patients received 2 intravenous (IV) injections: 1 mg of folic acid (to reduce the uptake of FolateScan in normal tissues), followed 1 to 3 minutes later by 0.1 mg of EC20 labeled with 15 to 25 mCi of technetium-99m (99mTc) over 30 seconds in a total injection volume of 1 to 2 mL.2 Each injection was given as a slow IV push via a free-flowing indwelling IV catheter in an upper extremity vein (i.e., in the antecubital fossa).

Drug: Tc 99m EC20

Interventions

Tc 99m EC20 DRUG

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.
• Subject must be 18 years of age or older.
• Subject must have known or strongly suspected ovarian carcinoma or recurrent endometrial carcinoma with at least one identifiable lesion \> 1.5 cm as diagnosed by ultrasonography, MRI, or CT.
• Subject must have good kidney function.
• Subject must provide written informed consent prior to enrollment.

You may not qualify if:

• Subjects must be excluded if any of the following conditions are present:
• Subject is pregnant or breastfeeding.
• Subject is simultaneously participating in another investigational 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

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

• Val J Lowe, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 21, 2012
• Study Start: August 1, 2003
• Study Completion: August 1, 2005
• Last Updated: June 22, 2023

Record last verified: 2012-09