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 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT07146295
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18 years old.
* DCIS or invasive breast cancer, confirmed by biopsy
* Clinically node-negative, confirmed by preoperative axillary ultrasound
* Indication for breast cancer surgery with SLN procedure via axillar incision
Exclusion Criteria:
* Combined MARI procedure
* Known allergy for Indocyanine Green (ICG), intravenous contrast or iodine
* History of axillary lymph node dissection
* Hyperthyroidism or thyroid cancer
* Pregnancy or breast-feeding
* No written informed consent according to ICH/GCP and national regulations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07146295
Study Brief:
Protocol Section:
NCT07146295