Comparison of core needle breast biopsy techniques: freehand versus three-dimensional US guidance.
OBJECTIVE
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.


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.


CONCLUSIONS
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.
Smith
Wendy L
WL
Imaging Research Laboratories, The John P. Robarts Research Institute, PO Box 5015, 100 Perth Dr, London, Ontario, Canada.
Surry
Kathleen J M
KJ
Kumar
Anu
A
McCurdy
Lauren
L
Downey
Donal B
DB
Fenster
Aaron
A
D000818:Animals; D001707:Biopsy, Needle / Q000295:instrumentation / Q000379:methods*; D001940:Breast / Q000473:pathology*; D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology*; D002645:Chickens; D005260:Female; D021621:Imaging, Three-Dimensional; D019047:Phantoms, Imaging; D013909:Thorax / Q000000981:diagnostic imaging / Q000473:pathology; D016217:Ultrasonography, Mammary / Q000379:methods*