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 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT02065232
Eligibility Criteria:
Inclusion Criteria:
* The patient has a diagnosis of biopsy-proven primary breast cancer or a diagnosis of pure ductal carcinoma in situ (DCIS) who will be undergoing intraoperative lymphatic mapping as part of their standard surgical plan.
* The patient has provided written informed consent before participating in the study, as has his/her responsible caregiver, if applicable.
* The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.
* The patient is greater than 18 years of age at the time of consent.
* The patient has an performance status of Grade 0 - 2.
* The patient has a clinical negative node status at the time of study entry.
* If the patients is of child bearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of radiopharmaceutical, has been surgically sterilized, or has been postmenopausal for at least 1 year.
Exclusion Criteria:
* The patient is pregnant or lactating.
* The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02065232
Study Brief:
Protocol Section:
NCT02065232