Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation
N/A
N/A
Female
Breast Cancer
Trial Information
Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Highly suspicious breast lesion on prior mammogram and/or ultrasound with
confirmation of malignancy on ultrasound-guided core biopsy
- Tumor no greater than 2.0 cm in diameter
- Eligible for lumpectomy or mastectomy
- No superficial breast lesions
- No prior open surgical biopsy
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Any age
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
- No other surgery that would preclude study participation
Other:
- No other medical treatment that would preclude study participation
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Helena R. Chang, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
UCLA-9908076
NCT ID:
NCT00020852
Start Date:
May 2001
Completion Date:
July 2004
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
