Spots Global Cancer Trial Database for Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

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Trial Identification

Brief Title: Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

Official Title: Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer

Study ID: NCT01992250

Conditions

Breast Cancer

Interventions

Visica 2 Treatment System

Study Description

Brief Summary: This study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer. The hypothesis is that cryoablation will complete ablation and destroy the tumor in a selected population of women who may otherwise be adequately treated with surgery.

Detailed Description: PURPOSE: To determine the rate of successful tumor ablation in patients treated with cryoablation and endocrine therapy in a subset of patients with early stage breast cancer. OUTLINE: 1. Core Biopsy (Pre-Registration) 2. Magnetic Resonance Imaging (Pre-Registration) 3. Tumor Cryoablation 4. Core Biopsy (Post-Cryoablation) 5. Magnetic Resonance Imaging (Post-Cryoablation) 6. Postoperative Follow-up 7. Evaluation of outcomes