NCT00020852

Cryosurgery in Treating Women With Breast Lesions

Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	conventional surgery
PROCEDURE	cryosurgery

Timeline

• Start date: 2001-05-01
• Completion: 2004-07-01
• First posted: 2003-01-27
• Last updated: 2013-05-30

Locations

1 site across 1 country: United States