Cryotherapy for Breast Cancer Trial

Breast Carcinoma Clinical Trial

— ICE-BREACCER  

Official title:

Evaluation of Safety and Feasibility of ICE-SENSE3TM , a Cryotherapy Device for Office-based Ultrasound- Guided Treatment of Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671943
• Other study ID #: ICMBC-01
• Status: Completed
• Phase: N/A
• First received: June 27, 2012
• Last updated: February 5, 2015
• Start date: August 2012
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: IceCure Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Device:
• Ice-Sense3TM
Ice-Sense Cryoprobe

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
IceCure Medical Ltd.

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse events	To describe the adverse events associated with cryoablation in these patients.	One month	Yes
Secondary	Pain assessment	To prospectively gather pain assessment data before and after cryoablation and after surgical resection in these patients	One month	No