A Phase 1 interventional study of Tc 99m EC20 in Ovarian Cancer and Endometrial Cancer, sponsored by Endocyte. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Endocyte · Phase 1, Interventional, and Other
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.
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Endocyte is the lead sponsor of 29 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must meet the following eligibility requirements to be enrolled in the study.
Exclusion Criteria:
Subjects must be excluded if any of the following conditions are present:
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
Each subject will receive 1 mg of folic acid injected 1-3 minutes prior to administration of Technetium Tc 99m EC20.
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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