Percutaneous Removal and Margin Ablation for Breast Cancer - Full Text View

Sponsors and Collaborators:	University of Arkansas Department of Health and Human Services Ethicon Endo-Surgery RITA Medical Systems
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00574301

Purpose

We hypothesize that radiofrequency ablation after single-insertion image guided vacuum assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast cancers (≤1.5 cm).

Condition	Intervention	Phase
Breast Cancer	Procedure: Percutaneous Removal and Margin Ablation	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Percutaneous Removal and Margin Ablation for Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy Surgery

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation [ Time Frame: Post-surgical pathology review ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of patients with viable tumor cells beyond the margin [ Time Frame: Post-surgical pathology review ] [ Designated as safety issue: No ]

Estimated Enrollment:	92
Study Start Date:	March 2002
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Procedure: Percutaneous Removal and Margin Ablation Patients with a diagnosis of unicentric invasive breast cancer diagnosed by IVEB will then be assigned to the next available surgery date. On that day, the patient's axillary staging will be done, followed by ablation of the biopsy cavity using RFA. The breast surgery may include lumpectomy (which will be directed with US-guidance to assure more accurate removal of the en bloc IVEB site and the margin zone of ablation) or simple mastectomy with or without reconstruction. The tissue specimen will be sent immediately from the operating room to Pathology for routine processing.

Arms

Assigned Interventions

1: Experimental

Procedure: Percutaneous Removal and Margin Ablation

Patients with a diagnosis of unicentric invasive breast cancer diagnosed by IVEB will then be assigned to the next available surgery date. On that day, the patient's axillary staging will be done, followed by ablation of the biopsy cavity using RFA. The breast surgery may include lumpectomy (which will be directed with US-guidance to assure more accurate removal of the en bloc IVEB site and the margin zone of ablation) or simple mastectomy with or without reconstruction. The tissue specimen will be sent immediately from the operating room to Pathology for routine processing.

Detailed Description:

Using the Mammotome Breast Biopsy System (IVEB) in conjunction with MRI to predict extent of disease, ultrasound to direct removal of the tumor, touch preparation cytology for diagnosis, and ablation of margins using radiofrequency ablation (RFA), we propose to develop a comprehensive system for same-day diagnosis and treatment of patients with small breast lesions.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female, 18 to 90 years of age
Non-pregnant, not breastfeeding
Pre-study documentation of:
Size ≤1.5 cm cancer successfully removed by US-guided IVEB within 30 days of registration
Uni-centricity, unilateral cancer by radiology (mammogram and MRI)
Location of abnormality > 1 cm from the skin
Ductal Carcinoma, Invasive (Grade I-III) or In-Situ
No palpable axillary or supraclavicular lymph nodes
Good general health
Zubrod Performance Status of 0, 1, or 2
If prior non-breast malignancy, must have 5 year disease-free survival
No prior chemotherapy
Hormonal therapy must be stopped
Therapy with tamoxifen must have been of 14 days or less duration

Exclusion Criteria:

Subjects less than 18 years of age or greater than 90 years of age
Pregnant or breastfeeding
Male
Prior Breast Biopsy affected breast
Breast implants
Multicentric disease, bilateral disease
Residual disease after IVEB of > 1cm on MRI
Lesions > 1.5 cm in diameter
Lesions < 1 cm from skin surface
Previous radiation therapy to the breast

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574301

Contacts

Contact: Laura Adkins, MAP, CCRP	501-296-1501 ext 1123	lladkins@uams.edu
Contact: Maureen Smith, RNP	501-296-1505 ext 1115	smithmaureena@uams.edu

Locations

United States, Arkansas
University of Arkansas For Medical Sciences	Recruiting
Little Rock, Arkansas, United States, 72205
Principal Investigator: V. Suzanne Klimberg, MD

Sponsors and Collaborators

University of Arkansas

Department of Health and Human Services

Ethicon Endo-Surgery

RITA Medical Systems

Investigators

Principal Investigator:

V. Suzanne Klimberg, MD

University of Arkansas

More Information

Publications:

Johnson AT, Henry-Tillman RS, Smith LF, Harshfield D, Korourian S, Brown H, Lane S, Colvert M, Klimberg VS. Percutaneous excisional breast biopsy. Am J Surg. 2002 Dec;184(6):550-4; discussion 554.

Responsible Party:	University of Arkansas for Medical Sciences ( V. Suzanne Klimberg )
Study ID Numbers:	UAMS 07050, NIH Grant 5 R21 CA097715-01
Study First Received:	December 14, 2007
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00574301 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arkansas:

Image Guided Vacuum Assisted Biopsy
Radiofrequency Ablation
Breast Conservation Therapy
Mastectomy
MRI

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009