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Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation
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.
OBJECTIVES: * 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.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Start Date
May 1, 2001
Completion Date
July 1, 2004
Last Updated
May 30, 2013
conventional surgery
PROCEDURE
cryosurgery
PROCEDURE
Lead Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
NCT05673200
NCT05372640
Data Source & Attribution
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