Spots Global Cancer Trial Database for Cryosurgery in Treating Women With Breast Lesions
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Trial Identification
Brief Title: Cryosurgery in Treating Women With Breast Lesions
Official Title: Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation
Study ID: NCT00020852
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Contact Details
Name: Helena R. Chang, MD, PhD
Affiliation: Jonsson Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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