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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer of the Breast

Intervention / Treatment
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* Device: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Requiring 2nd Surgery for Close or Positive Margins | 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. | Margins assessed at Final Pathology, approximately 1 week post-RF surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Breast Cancer at Prior Site of Disease |  | Until study end (2 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Lumpectomy, Radiofrequency Ablation, Negative margins, Breast Conserving Surgery