Stereotactic Guided Biopsy and Cryoablation (NCT07439432) | Clinical Trial Compass
WithdrawnNot Applicable
Stereotactic Guided Biopsy and Cryoablation
Stopped: Study never approved by the Albert Einstein College of Medicine IRB.
0Started 2025-10
Plain-language summary
The purpose of this study is to evaluate a new strategy to treat small breast cancer called cryoablation, or cryosurgery, in combination with biopsy methods which are guided by certain imaging like mammography.
Who can participate
Age range60 Years
SexFEMALE
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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)).
What they're measuring
1
Overall feasibility
Timeframe: Up to 5 Years
2
Feasibility - Procedure Completeness
Timeframe: Within 1 month post procedure (+/- 7 days)
3
Feasibility - Data Completeness
Timeframe: Up to 5 Years
4
Study Safety
Timeframe: Day of procedure and within 1-month post-procedure (+/- 7 days)