NCT00574301
Completed
Phase 1
Percutaneous Removal and Margin Ablation for Breast Cancer
ConditionsBreast Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University of Arkansas
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •Subjects less than 18 years of age or greater than 90 years of age
- •Pregnant or breastfeeding
- •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
Outcomes
Primary Outcomes
To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation
Time Frame: Post-surgical pathology review
Secondary Outcomes
- The proportion of patients with viable tumor cells beyond the margin(Post-surgical pathology review)
Study Sites (1)
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