Percutaneous Removal and Margin Ablation for Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Ethicon Endo-Surgery
RITA Medical Systems
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00574301
First received: December 14, 2007
Last updated: July 24, 2013
Last verified: July 2013
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Percutaneous Removal and Margin Ablation for Breast Cancer

Resource links provided by NLM:


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 ]

Enrollment: 32
Study Start Date: March 2002
Study Completion Date: October 2011
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Other Names:
  • Mammotome Breast Biopsy System (IVEB), Ethicon Endo-Surgery
  • Radiofrequency Ablation (RFA), RITA Medical Systems
  • Lumpectomy
  • Mastectomy

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arkansas
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Ethicon Endo-Surgery
RITA Medical Systems
Investigators
Principal Investigator: V. Suzanne Klimberg, MD University of Arkansas
  More Information

Publications:
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00574301     History of Changes
Other Study ID Numbers: UAMS 07050, NIH Grant 5 R21 CA097715-01
Study First Received: December 14, 2007
Last Updated: July 24, 2013
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 01, 2014