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Percutaneous Removal and Margin Ablation for Breast Cancer

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ClinicalTrials.gov Identifier: NCT00574301
Recruitment Status : Completed
First Posted : December 17, 2007
Last Update Posted : July 25, 2013
Sponsor:
Collaborators:
Department of Health and Human Services
Ethicon Endo-Surgery
RITA Medical Systems
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Procedure: Percutaneous Removal and Margin Ablation Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Removal and Margin Ablation for Breast Cancer
Study Start Date : March 2002
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The proportion of patients with viable tumor cells beyond the margin [ Time Frame: Post-surgical pathology review ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574301


Locations
United States, Arkansas
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
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

Publications of Results:
Other 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
First Posted: December 17, 2007    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013

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