ICE-BREACCER: Cryotherapy for Breast Cancer Trial
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the clinical feasibility and safety of the ICESENSE3TM cryotherapy system for the ablation of small malignant invasive breast tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Breast carcinoma up to 2.0 cm
|
Device: Ice-Sense3TM
Ice-Sense Cryoprobe
|
Outcome Measures
Primary Outcome Measures
- The rate of complete tumor ablation in patients treated with cryoablation, with complete tumor ablation defined as no remaining invasive or in-situ carcinoma present upon pathological examination of the surgical resection specimen [One month]
Secondary Outcome Measures
- Adverse events [One month]
To describe the adverse events associated with cryoablation in these patients.
- Pain assessment [One month]
To prospectively gather pain assessment data before and after cryoablation and after surgical resection in these patients
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
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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.
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Tumor enhancement on MRI
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Tumor with <25% intraductal components in the aggregate.
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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.
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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.
Exclusion Criteria:
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Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive DCIS.
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History of rotational vacuum assisted core biopsies, en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
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Prior or planned neoadjuvant chemotherapy for breast cancer.
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Patients with thrombocytopenia and or any other coagulation abnormality
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague Prague, Czech Republic | Prague | Czech Republic |
Sponsors and Collaborators
- IceCure Medical Ltd.
Investigators
- Principal Investigator: David Pavlista, MD,
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ICMBC-01