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
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.
Study Phase
Phase 1
Study Type
Interventional
Condition
Ovarian Cancer
Intervention
Tc 99m EC20
Study Arms / Comparison Groups
Tc 99m EC20
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
August 2001
Primary Completion Date
August 2004
Eligibility Criteria
Inclusion Criteria:
- Subjects must meet the following eligibility requirements to be enrolled in the study.
1. Subjects must be female, 18 years of age or older.
2. 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.
3. 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.
4. Subjects must provide written informed consent prior to enrollment.
5. 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:
1. Subject is pregnant or breast-feeding.
2. Subject is simultaneously participating in another investigative drug study.
3. Subject has completed the follow-up phase of any previous study less than 30 days
prior to enrollment in this study.
4. Subject is unable to tolerate conditions for radionuclide imaging.
5. Subject has been administered another radiopharmaceutical that would interfere
with the assessment of Technetium Tc 99m EC20.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
James W. Fletcher, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01686256
Organization ID
EC20.2
Responsible Party
Sponsor
Study Sponsor
Endocyte
Study Sponsor
James W. Fletcher, MD, Principal Investigator, Indiana University
Verification Date
September 2012