We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cryosurgery in Treating Women With Breast Lesions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00020852
First Posted: January 27, 2003
Last Update Posted: May 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
July 11, 2001
January 27, 2003
May 30, 2013
May 2001
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00020852 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Interventional
Phase 1
Primary Purpose: Treatment
Breast Cancer
  • Procedure: conventional surgery
  • Procedure: cryosurgery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
July 2004
Not Provided

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
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00020852
UCLA-9908076
CDR0000068724 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-G01-1964
Not Provided
Not Provided
Not Provided
Not Provided
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Helena R. Chang, MD, PhD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
May 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP