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 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT05118295
Eligibility Criteria:
Inclusion Criteria:
1. Female or male patients \>18 years of age at the time of consent.
2. Unifocal BIRADS-5 or -6 lesions at the time of diagnostic imaging
3. Unifocal, histologically-proven T0-T3, N0-1 invasive breast cancer at the time of mid-chemotherapy imaging if receiving neoadjuvant therapy
Exclusion criteria
1. Distant metastasis
2. Inflammatory breast carcinoma
3. Nickel allergy
4. Patients with active cardiac implants
5. Patients participating in Protocol 2016-0046, Multicenter Trial for Eliminating Breast Cancer Surgery in Exceptional Responders to Neoadjuvant Therapy
6. Patients participating in Protocol AFT-25, Comparison of Operative to Monitoring and Endocrine Therapy for Low-risk DCIS (COMET)
7. Pregnant women will be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05118295
Study Brief:
Protocol Section:
NCT05118295