Cryoablation for Invasive Breast Carcinoma Following Neoadjuvant Therapy
Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue.
The goal of this clinical research study is to learn about the level of effectiveness of using ultrasound-guided cryoablation in patients with invasive breast cancer. The safety of this procedure will also be studied.
|Breast Cancer||Device: Visica 2™ Treatment System Procedure: Cryoablation Procedure: Surgical Resection||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Determine the Efficacy of Cryoablation for the Treatment of Invasive Breast Carcinoma Following Neoadjuvant Therapy|
- Rate of Complete Ablation [ Time Frame: 2-4 weeks after cryoablation ]Complete ablation is defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion. The rate computed as the number of patients with complete tumor ablation divided by the total number of eligible patients.
|Actual Study Start Date:||January 24, 2012|
|Study Completion Date:||June 14, 2017|
|Primary Completion Date:||June 14, 2017 (Final data collection date for primary outcome measure)|
Cryoablation therapy followed by re-imaging then complete surgical resection.
Device: Visica 2™ Treatment System
The Visica 2™ Treatment System uses a closed system to circulate liquid nitrogen within the probe tip creating sub-freezing temperatures that result in precision cryoablation of the intended target tissue.Procedure: Cryoablation
Cryoablation procedure uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. The cryoprobe needle insertion is done using ultrasound guide to reach target, procedure lasts about 20 minutes.Procedure: Surgical Resection
Complete surgical resection of the primary tumor following cryoablation therapy.
Other Name: Surgery
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01388777
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Rosa Hwang, MD||M.D. Anderson Cancer Center|