Back to resultsSafety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer
Primary Purpose
Ovarian Cancer, Endometrial Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tc 99m EC20
Sponsored by
About this trial
This is an interventional other trial for Ovarian Cancer focused on measuring Ovarian Cancer, Endometrial Cancer
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Sites / Locations
- Indiana University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tc 99m EC20
Arm Description
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.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01686256
Brief Title
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endocyte
4. Oversight
5. Study Description
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.
Detailed Description
The study is 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.
Women with a suspected ovarian or endometrial mass who either 1) have fixed, paraffin embedded tissue sample(s) available for immunohistochemical staining obtained from a previous pathological evaluation or 2) are scheduled for a procedure to obtain tissue for pathological evaluation that can be fixed and paraffin embedded for immunohistochemical staining are eligible for this study. The ovarian mass may be either an initial finding, e.g., found at a routine pelvic examination or to investigate symptoms, or the ovarian or endometrial mass may be a finding suspicious of recurrent or residual tumor at follow-up examination after surgical resection of confirmed ovarian or endometrial cancer. Patients may not be pregnant or breastfeeding at enrollment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Endometrial Cancer
Keywords
Ovarian Cancer, Endometrial Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tc 99m EC20
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tc 99m EC20
Intervention Description
Each subject will receive 1 mg of folic acid injected 1-3 minutes prior to administration of Technetium 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.
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James W. Fletcher, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer
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