Breast Cancer
Conditions
Keywords
Image Guided Vacuum Assisted Biopsy, Radiofrequency Ablation, Breast Conservation Therapy, Mastectomy, MRI
Brief summary
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
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.
Interventions
PROCEDUREPercutaneous Removal and Margin Ablation
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.
Sponsors
Department of Health and Human Services
Ethicon Endo-Surgery
RITA Medical Systems
University of Arkansas
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| The proportion of patients with viable tumor cells beyond the margin | Post-surgical pathology review |
Countries
United States
Outcome results
None listed