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Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation (eRFA)

This study has been completed.
Sponsor:
Collaborator:
Angiodynamics, Inc.
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00571987
First received: December 11, 2007
Last updated: October 28, 2015
Last verified: October 2015

December 11, 2007
October 28, 2015
September 2004
June 2013   (final data collection date for primary outcome measure)
Number of Patients Requiring 2nd Surgery for Close or Positive Margins [ Time Frame: Margins assessed at Final Pathology, approximately 1 week post-RF surgery ] [ Designated as safety issue: No ]
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.
Margin Status [ Time Frame: Final surgical pathology review ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00571987 on ClinicalTrials.gov Archive Site
Recurrence of Breast Cancer at Prior Site of Disease [ Time Frame: Until study end (2 years) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
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.
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.
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer of the Breast
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.
1
This is a non-randomized one arm study, all subjects receive treatment (radiofrequency ablation).
Intervention: Device: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
December 2013
June 2013   (final data collection date for primary outcome measure)

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)
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00571987
UAMS 29143
No
Not Provided
Not Provided
University of Arkansas
University of Arkansas
Angiodynamics, Inc.
Principal Investigator: V. Suzanne Klimberg, M.D. University of Arkansas
University of Arkansas
October 2015

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