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

University of Arkansas

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cancer of the Breast

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00571987

UAMS 29143

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

1

Other group

Description:

This is a non-randomized one arm study, all subjects receive treatment (radiofrequency ablation).

Treatment:

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