Comparison of Core Needle Breast Biopsy Techniques: Freehand versus Three-Dimensional US Guidance

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, α, 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.