Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Angiodynamics, Inc.
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00571987
First received: December 11, 2007
Last updated: January 16, 2014
Last verified: January 2014

December 11, 2007
January 16, 2014
September 2004
June 2014   (final data collection date for primary outcome measure)
Margin Status [ Time Frame: Final surgical pathology review ] [ Designated as safety issue: No ]
Same as current
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
Allocation: Non-Randomized
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.
No Intervention: 1
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.
 
Active, not recruiting
107
June 2014
June 2014   (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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00571987
UAMS 29143
No
University of Arkansas
University of Arkansas
Angiodynamics, Inc.
Principal Investigator: V. Suzanne Klimberg, M.D. University of Arkansas
University of Arkansas
January 2014

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