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Cryotherapy for Breast Cancer Trial (ICE-BREACCER)

This study is currently recruiting participants.
Verified February 2013 by IceCure Medical Ltd.
Sponsor:
Information provided by (Responsible Party):
IceCure Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01671943
First received: June 27, 2012
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

  • Pain assessment [ Time Frame: One month ] [ Designated as safety issue: No ]
    To prospectively gather pain assessment data before and after cryoablation and after surgical resection in these patients


Estimated Enrollment: 10
Study Start Date: August 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671943

Contacts
Contact: Elisabeth Sadka +972-4-6230333 ext 223 Elisabeth@icecure-medical.com

Locations
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 Recruiting
Prague, Czech Republic
Principal Investigator: David Pavlista, MD            
Sponsors and Collaborators
IceCure Medical Ltd.
Investigators
Principal Investigator: David Pavlista, MD
  More Information

No publications provided

Responsible Party: IceCure Medical Ltd.
ClinicalTrials.gov Identifier: NCT01671943     History of Changes
Other Study ID Numbers: ICMBC-01
Study First Received: June 27, 2012
Last Updated: February 7, 2013
Health Authority: Czech Republic: Ethics Committee

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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 16, 2013