Cryosurgery in Treating Women With Breast Lesions
|ClinicalTrials.gov Identifier: NCT00020852|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 30, 2013
RATIONALE: Cryosurgery kills cancer cells by freezing them. Cryosurgery followed by lumpectomy or mastectomy may be an effective treatment for breast lesions.
PURPOSE: Phase I trial to study the effectiveness of cryosurgery in treating women who have breast lesions.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: conventional surgery Procedure: cryosurgery||Phase 1|
- Determine the feasibility of temperature-monitored, ultrasound-guided cryosurgery in women with highly suspicious breast lesions.
- Determine the safety of this procedure in these patients.
OUTLINE: This is a multicenter study.
Patients undergo cryoablation of up to two breast lesions. Within 3-21 days, patients undergo lumpectomy or mastectomy.
Patients are followed at 1, 4, 8, and 12 weeks after lumpectomy or mastectomy.
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation|
|Study Start Date :||May 2001|
|Actual Study Completion Date :||July 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020852
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-7028|
|Principal Investigator:||Helena R. Chang, MD, PhD||Jonsson Comprehensive Cancer Center|