Cryotherapy for Breast Cancer Trial

Not Applicable

Completed

• Conditions: Breast Carcinoma
• Interventions: Device: Ice-Sense3TM

• Registration Number: NCT01671943
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-27
• Study Start: 2012-08
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-24
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-05
• Last Update Posted: 2015-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast carcinoma up to 2.0 cm	Ice-Sense3TM	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pain assessment	One month	To prospectively gather pain assessment data before and after cryoablation and after surgical resection in these patients
Adverse events	One month	To describe the adverse events associated with cryoablation in these patients.

Trial Locations

Locations (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