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.
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.