Percutaneous Removal and Margin Ablation for Breast Cancer

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Percutaneous Removal and Margin Ablation

• Registration Number: NCT00574301
• Lead Sponsor: University of Arkansas

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.

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2007-10
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-17
• Study Completion: 2011-10
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-24
• Last Update Posted: 2013-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Percutaneous Removal and Margin Ablation	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The proportion of patients with viable tumor cells beyond the margin	Post-surgical pathology review

Trial Locations

Locations (1)

University of Arkansas For Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States