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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07439432
Eligibility Criteria:
Inclusion Criteria:
* Age 60 years or older, European Cooperative Oncology Group (ECOG) score 0-2
* Lesion size 1.0 cm or smaller in greatest diameter. The largest diameter will be determined at the time of the diagnostic work up. For targets that are imaged in multiple modalities the largest diameter will prevail in determining eligibility. Note- 1.0 cm target size is chosen since extent may be underestimated upon initial diagnosis.
* Biopsy proven DCIS, (including any lesion with DCIS +/- IDC)
* Closest margin of target to the skin \>15 mm
* Compressed breast thickness to \> 55mm
* Unifocal primary disease (Patients with contralateral disease will remain eligible.)
* Able to provide consent
Exclusion Criteria:
* Multifocal or multicentric disease within the breast.
* Prior surgical biopsy for diagnosis or treatment of index lesion.
* Patients not suitable for stereotactic biopsy/cryoablation technique according to treating physician.
* Patients receiving neoadjuvant therapy.
* History of previously treated ipsilateral or contralateral breast carcinoma is not an exclusion criterion if the investigator is certain newly diagnosed carcinoma is a new unifocal primary tumor.
* High-risk pathology (e.g., Grade 3, HER2+ status, Genomic high-risk score (if available)).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
60 Years
Study:
NCT07439432
Study Brief:
Protocol Section:
NCT07439432