Cryotherapy for Breast Cancer Trial (ICE-BREACCER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01671943
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : February 6, 2015
Information provided by (Responsible Party):
IceCure Medical Ltd.

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
Breast Carcinoma Device: Ice-Sense3TM Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Breast carcinoma up to 2.0 cm Device: Ice-Sense3TM
Ice-Sense Cryoprobe

Primary Outcome Measures :
  1. 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 :
  1. Adverse events [ Time Frame: One month ]
    To describe the adverse events associated with cryoablation in these patients.

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: IceCure Medical Ltd. Identifier: NCT01671943     History of Changes
Other Study ID Numbers: ICMBC-01
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 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