Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT01686256
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01686256
Study Brief:
Protocol Section:
NCT01686256