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Trial record 1 of 1 for:    NCT00571987
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Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation (eRFA)

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ClinicalTrials.gov Identifier: NCT00571987
Recruitment Status : Completed
First Posted : December 12, 2007
Results First Posted : October 6, 2015
Last Update Posted : November 24, 2015
Angiodynamics, Inc.
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This combination method will provide for excision of the cancer as routinely accomplished and ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing large volumes of tissue. This combined open technique will allow for full histologic analysis of the primary tumor and margin. Because no extra tissue is removed from the breast to generate negative margins it will result in better cosmesis than re-excision to obtain negative margins.

Condition or disease Intervention/treatment Phase
Cancer of the Breast Device: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe) Phase 1 Phase 2

Detailed Description:
While RFA alone is not approved for tumor destruction in breast it is FDA-approved for ablation of soft tissue after the breast cancer is removed. This study seeks to remove the tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site instead of removing more tissue. The primary short-term goal is to obviate the need for re-excision in the event of close or positive margins (< 3 mm) which occurs on average in ~40 percent of the cases. Permanent pathology is only an estimation of margin status since 90% of recurrences occur at the site of the original lumpectomy. RFA ensures a sterilized margin regardless of the accuracy of the permanent pathology.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
Study Start Date : September 2004
Primary Completion Date : June 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
This is a non-randomized one arm study, all subjects receive treatment (radiofrequency ablation).
Device: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)
Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.

Primary Outcome Measures :
  1. Number of Patients Requiring 2nd Surgery for Close or Positive Margins [ Time Frame: Margins assessed at Final Pathology, approximately 1 week post-RF surgery ]
    A "close" surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a "wide" surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined "close" as less than 3 mm.

Secondary Outcome Measures :
  1. Recurrence of Breast Cancer at Prior Site of Disease [ Time Frame: Until study end (2 years) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female, 18-100 years old
  • Not pregnant or breastfeeding
  • Pre-study radiologic documentation of:
  • size ≤ 5 cm
  • unicentric, unilateral
  • suspicious mass or calcification
  • BIRADS classification ≥ IV
  • location of abnormality > 1 cm from skin
  • Ductal or Infiltrating Ductal Carcinoma
  • Grade I-III on final pathology
  • Good general health
  • Zubrod Performance Status of 0,1, or 2
  • No previous chemotherapy
  • No palpable axillary or supraclavicular lymph nodes
  • If prior non-breast malignancy, must have > 5 year disease-free survival

Exclusion Criteria:

  • Patient < 18 y/o or > 100 y/o
  • Pregnant or breastfeeding
  • Male
  • Breast implants
  • Multicentric disease or bilateral disease
  • Lesions > 5 cm in diameter
  • Lesions < 1.0 cm from the skin
  • Previous prior radiation to the breast
  • Need for mastectomy
  • Diffuse microcalcifications (as determined by the Investigator)

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): NCT00571987

United States, Arkansas
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Angiodynamics, Inc.
Principal Investigator: V. Suzanne Klimberg, M.D. University of Arkansas

Additional Information:
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00571987     History of Changes
Other Study ID Numbers: UAMS 29143
First Posted: December 12, 2007    Key Record Dates
Results First Posted: October 6, 2015
Last Update Posted: November 24, 2015
Last Verified: October 2015

Keywords provided by University of Arkansas:
Breast cancer
Radiofrequency Ablation
Negative margins
Breast Conserving Surgery

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