Back to resultsSafety and Efficacy of Folatescan (Technetium TC 99M EC20) in Patients With Suspected Ovarian Carcinoma or Recurrent Endometrial Carcinoma
Primary Purpose
Ovarian Carcinoma, Recurrent Endometrial Carcinoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tc 99m EC20
Sponsored by
About this trial
This is an interventional other trial for Ovarian Carcinoma focused on measuring Ovarian Carcinoma, Recurrent Endometrial Carcinoma
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tc 99m EC20
Arm Description
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).
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01689714
Brief Title
Safety and Efficacy of Folatescan (Technetium TC 99M EC20) in Patients With Suspected Ovarian Carcinoma or Recurrent Endometrial Carcinoma
Official Title
A MULTI-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FOLATESCAN (TECHNETIUM Tc 99m EC20) IN PATIENTS WITH SUSPECTED OVARIAN CARCINOMA OR RECURRENT ENDOMETRIAL CARCINOMA
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endocyte
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This phase 2, two-center, open-label, single-treatment group, within-patient-controlled study was conducted to:
Expand the safety database and gather data on the percentage of patients with known or suspected ovarian carcinoma or recurrent endometrial carcinoma who show increased uptake of FolateScan in tumors (primary objective).
Calculate the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared with immunohistochemical (IHC) staining (secondary objective).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Carcinoma, Recurrent Endometrial Carcinoma
Keywords
Ovarian Carcinoma, Recurrent Endometrial Carcinoma
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tc 99m EC20
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Tc 99m EC20
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Val J Lowe, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Folatescan (Technetium TC 99M EC20) in Patients With Suspected Ovarian Carcinoma or Recurrent Endometrial Carcinoma
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