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Cryotherapy for Breast Cancer Trial (ICE-BREACCER)

This study has been completed.
Information provided by (Responsible Party):
IceCure Medical Ltd. Identifier:
First received: June 27, 2012
Last updated: February 5, 2015
Last verified: February 2015
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 Intervention
Breast Carcinoma
Device: Ice-Sense3TM

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Feasibility of ICE-SENSE3TM , a Cryotherapy Device for Office-based Ultrasound- Guided Treatment of Breast Cancer

Resource links provided by NLM:

Further study details as provided by IceCure Medical Ltd.:

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 [ Time Frame: One month ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: One month ]
    To describe the adverse events associated with cryoablation in these patients.

  • Pain assessment [ Time Frame: One month ]
    To prospectively gather pain assessment data before and after cryoablation and after surgical resection in these patients

Enrollment: 4
Study Start Date: August 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breast carcinoma up to 2.0 cm Device: Ice-Sense3TM
Ice-Sense Cryoprobe


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01671943

Czech Republic
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.
Principal Investigator: David Pavlista, MD
  More Information

Responsible Party: IceCure Medical Ltd. Identifier: NCT01671943     History of Changes
Other Study ID Numbers: ICMBC-01
Study First Received: June 27, 2012
Last Updated: February 5, 2015

Keywords provided by IceCure Medical Ltd.:
small malignant invasive breast tumors

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on March 29, 2017