Clinical trial · Interventional
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer
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
NCT01686256CI-TRIAL-00067461completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tc 99m EC20 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Drug: Tc 99m EC20
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.