Evaluation of Safety and Feasibility of ICE-SENSE3TM , a Cryotherapy Device for Office-based Ultrasound- Guided Treatment of Breast Cancer
- Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy.
Patients with contralateral disease will remain eligible. Note: Results of ER, PR,
HER-2/neu must be obtained on pre-registration needle core biopsy material.
- Tumor size ≤ 2.0 cm in greatest diameter as measured by breast ultrasound, MRI and
mammogram. The largest dimension measured will be used to determine eligibility.
- Tumor enhancement on MRI
- Tumor with <25% intraductal components in the aggregate.
- Non-pregnant and non-lactating patients. Patients of childbearing potential must have
a negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be
amenorrheic for > 12 months to be considered not of childbearing potential.
- Adequate breast size for safe cryoablation. Patients with breasts too small to allow
safe cryoablation are not eligible as the minimal thickness of the breast tissue does
not lend itself to cryoablation. NOTE: The minimal distance of tumor margins from the
breast skin should be analogous to the surgical margins of a lumpectomy.
- Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal
calcifications, or evidence of excessive DCIS.
- History of rotational vacuum assisted core biopsies, en bloc open surgical biopsy
and/or lumpectomy for diagnosis/treatment of the index breast cancer.
- Prior or planned neoadjuvant chemotherapy for breast cancer.
- Patients with thrombocytopenia and or any other coagulation abnormality