Abstract：
RATIONALE AND OBJECTIVES:No single method is generally accepted for evaluating the accuracy of breast biopsy techniques before their clinical implementation. The purpose of this study was to test a new process for evaluating biopsy techniques by using it in the evaluation of a prototype three-dimensional ultrasound (US)-guided biopsy device. MATERIALS AND METHODS:The biopsy accuracy of a new three-dimensional US-guided breast biopsy device was compared to that of the accepted clinical practice of biopsy by expert radiologists with two-dimensional freehand US guidance. Biopsies were performed in chicken tissue phantoms containing 3.2-mm lesions made of poly(vinyl alcohol) cryogel. The criterion for a successful biopsy was the presence of lesion in the sample. The equivalence limit difference tested was 10% by using a power of 90% and a two-sided test significance level, a, of 10%. RESULTS:The biopsy success rate of the three-dimensional US-guided system (96%) was equivalent to that of expert radiologists using two-dimensional freehand US guidance (94.5%) in tissue phantoms containing poly(vinyl alcohol) cryogel lesions. CONCLUSION:This evaluation procedure is a valuable precursor to clinical trials in the assessment of biopsy techniques. The three-dimensional US-guided breast biopsy system provides a suitable alternative to two-dimensional freehand US guidance for biopsy of breast cancer.
journal_name
Acad Radioljournal_title
Academic radiologyauthors
Smith WL,Surry KJ,Kumar A,McCurdy L,Downey DB,Fenster Adoi
10.1016/s1076-6332(03)80331-8keywords:
subject
Has Abstractpub_date
2002-05-01 00:00:00pages
541-50issue
5eissn
1076-6332issn
1878-4046journal_volume
9pub_type
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