Percutaneous Removal and Margin Ablation for Breast Cancer

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

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).

Key facts

Study ID

NCT00574301

Run by

University of Arkansas

People needed

32

Starts

2002-03-01

Expected to finish

2011-10-01

Last updated by the study team

2013-07-25

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arkansas For Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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