Cryotherapy for Breast Cancer Trial

NCT ID: NCT01671943

Last Updated: 2015-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-07-31

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.

Conditions

Breast Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Breast carcinoma up to 2.0 cm

Group Type: EXPERIMENTAL

Ice-Sense3TM

Intervention Type: DEVICE

Ice-Sense Cryoprobe

Interventions

Ice-Sense3TM

Ice-Sense Cryoprobe

Intervention Type: DEVICE

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IceCure Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Pavlista, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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, , Czechia

Countries

Czechia

Other Identifiers

ICMBC-01

Identifier Type: -

Identifier Source: org_study_id