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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Cancer of the Breast

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Margin Status

Outcome Time Frame:

Final surgical pathology review

Safety Issue:

No

Principal Investigator

V. Suzanne Klimberg, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Institutional Review Board

Study ID:

UAMS 29143

NCT ID:

NCT00571987

Start Date:

September 2004

Completion Date:

January 2014

Related Keywords:

  • Cancer of the Breast
  • Breast cancer
  • Lumpectomy
  • Radiofrequency Ablation
  • Negative margins
  • Breast Conserving Surgery
  • Breast Neoplasms

Name

Location

University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205