Percutaneous Removal and Margin Ablation for Breast Cancer

Study Overview
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Brief Summary
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We hypothesize that radiofrequency ablation after single-insertion image guided vacuum assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast cancers (≤1.5 cm).

Detailed Description
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Using the Mammotome Breast Biopsy System (IVEB) in conjunction with MRI to predict extent of disease, ultrasound to direct removal of the tumor, touch preparation cytology for diagnosis, and ablation of margins using radiofrequency ablation (RFA), we propose to develop a comprehensive system for same-day diagnosis and treatment of patients with small breast lesions.

Official Title
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Percutaneous Removal and Margin Ablation for Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Percutaneous Removal and Margin Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, 18 to 90 years of age Non-pregnant, not breastfeeding Pre-study documentation of: Size ≤1.5 cm cancer successfully removed by US-guided IVEB within 30 days of registration Uni-centricity, unilateral cancer by radiology (mammogram and MRI) Location of abnormality > 1 cm from the skin Ductal Carcinoma, Invasive (Grade I-III) or In-Situ No palpable axillary or supraclavicular lymph nodes Good general health Zubrod Performance Status of 0, 1, or 2 If prior non-breast malignancy, must have 5 year disease-free survival No prior chemotherapy Hormonal therapy must be stopped Therapy with tamoxifen must have been of 14 days or less duration Exclusion Criteria: Subjects less than 18 years of age or greater than 90 years of age Pregnant or breastfeeding Male Prior Breast Biopsy affected breast Breast implants Multicentric disease, bilateral disease Residual disease after IVEB of > 1cm on MRI Lesions > 1.5 cm in diameter Lesions < 1 cm from skin surface Previous radiation therapy to the breast

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Percutaneous Removal and Margin Ablation<br>* Patients with a diagnosis of unicentric invasive breast cancer diagnosed by IVEB will then be assigned to the next available surgery date. On that day, the patient's axillary staging will be done, followed by ablation of the biopsy cavity using RFA. The breast surgery may include lumpectomy (which will be directed with US-guidance to assure more accurate removal of the en bloc IVEB site and the margin zone of ablation) or simple mastectomy with or without reconstruction. The tissue specimen will be sent immediately from the operating room to Pathology for routine processing.<br>* Other names: Mastectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation |  | Post-surgical pathology review | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with viable tumor cells beyond the margin |  | Post-surgical pathology review | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Image Guided Vacuum Assisted Biopsy, Radiofrequency Ablation, Breast Conservation Therapy, Mastectomy, MRI