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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT02589366
Eligibility Criteria:
Inclusion Criteria:
1. The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization.
2. The patient has diagnosed cancer of the endometrium.
3. The patient is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan.
4. The patient is at least 18 years of age at the time of consent.
5. The patient has an Eastern Cooperative Group (ECOG) performance status of Grade 0 - 2.
6. The patient has a clinical negative node status at the time of study entry (i.e., Tis-4, N0, M0).
7. If of childbearing potential, the patient has a negative pregnancy test within 72 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.
Exclusion Criteria:
1. The patient is pregnant or lactating.
2. The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T, N0, M0).
3. The patient has a known hypersensitivity to Lymphazurin or Lymphoseek.
4. The patient has participated in another investigational drug study within 30 days of scheduled surgery.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02589366
Study Brief:
Protocol Section:
NCT02589366