The development and evaluation of a three-dimensional ultrasound-guided breast biopsy apparatus

We have designed a prototype three-dimensional ultrasound guidance (3D USB) apparatus to improve the breast biopsy procedure. Features from stereotactic mammography and free-hand US-guided biopsy have been combined with 3D US imaging. This breast biopsy apparatus accurately guides a needle into position for the sampling of target tissue. We have evaluated this apparatus in three stages. First, by testing the placement accuracy of a needle in a tissue mimicking phantom. Second, with tissue mimicking phantoms that had embedded lesions for biopsy. Finally, by comparison to free-hand US-guided biopsy, using chicken breast phantoms. The first two stages of evaluation quantified the mechanical biases in the 3D USB apparatus. Compensating for these, a 96% success rate in targeting 3.2 mm "lesions" in chicken breast phantoms was achieved when using the 3D USB apparatus. The expert radiologists performing biopsies with free-hand US guidance achieved a 94.5% success rate. This has proven an equivalence between our apparatus, operated by non-experts, and free-hand biopsy performed by expert radiologists, for 3.2 mm lesions in vitro, with a 95% confidence.

[1]  F Puglisi,et al.  Percutaneous large core needle biopsy versus surgical biopsy in the diagnosis of breast lesions. , 1997, International surgery.

[2]  R. Brem,et al.  Fourteen‐gauge ultrasonographically guided large‐core needle biopsy of breast masses. , 2001, Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine.

[3]  John E. Freund,et al.  Probability and statistics for engineers , 1965 .

[4]  J Troccaz,et al.  Clinical results of percutaneous pelvic surgery. Computer assisted surgery using ultrasound compared to standard fluoroscopy. , 2001, Computer aided surgery : official journal of the International Society for Computer Aided Surgery.

[5]  D. Downey,et al.  Three-dimensional ultrasound-guided core needle breast biopsy. , 2001, Ultrasound in medicine & biology.

[6]  K. Hopper,et al.  Nonpalpable breast lesions: stereotactic automated large-core biopsies. , 1991, Radiology.

[7]  A Darzi,et al.  Interventional MR‐guided excisional biopsy of breast lesions , 1998, Journal of magnetic resonance imaging : JMRI.

[8]  T. Matalon,et al.  US guidance of interventional procedures. , 1990, Radiology.

[9]  T. Nelson,et al.  Three‐dimensional ultrasound , 1999, Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology.

[10]  L. Brinton,et al.  Recent trends in breast cancer incidence and mortality , 2002, Environmental and molecular mutagenesis.

[11]  L L Fajardo,et al.  MRI-guided needle localization: technique. , 2000, Seminars in ultrasound, CT, and MR.

[12]  D. Downey,et al.  Three-dimensional transrectal ultrasound guided cryoablation for localized prostate cancer in nonsurgical candidates: a feasibility study and report of early results. , 1998, The Journal of urology.

[13]  G. Glover,et al.  Breast lesion localization: a freehand, interactive MR imaging-guided technique. , 1998, Radiology.

[14]  R. Schmidt,et al.  Stereotactic breast biopsy , 1994, CA: a cancer journal for clinicians.

[15]  G A DeAngelis,et al.  Technique and pitfalls of ultrasound-guided core-needle biopsy of the breast. , 2000, Seminars in ultrasound, CT, and MR.

[16]  H. Verkooijen,et al.  Diagnostic accuracy of large-core needle biopsy for nonpalpable breast disease: a meta-analysis , 2000, British Journal of Cancer.

[17]  M. Westphal,et al.  Ultrasound-guided surgery of deep seated brain lesions. , 2000, European journal of ultrasound : official journal of the European Federation of Societies for Ultrasound in Medicine and Biology.

[18]  B. Rutt,et al.  Polyvinyl alcohol cryogel: An ideal phantom material for MR studies of arterial flow and elasticity , 1997, Magnetic resonance in medicine.

[19]  J. Meyer,et al.  The utility of ultrasonographically guided large‐core needle biopsy: results from 500 consecutive breast biopsies. , 2001, Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine.

[20]  K. Hopper,et al.  Stereotactic breast biopsy with a biopsy gun. , 1990, Radiology.

[21]  W. Kaiser,et al.  Robotic system for biopsy and therapy of breast lesions in a high-field whole-body magnetic resonance tomography unit. , 2000, Investigative radiology.

[22]  D. Downey,et al.  Three-dimensional ultrasound imaging , 1995, Medical Imaging.

[23]  E. Schneider,et al.  An apparatus for MR‐guided breast lesion localization and core biopsy: Design and preliminary results , 2001, Journal of magnetic resonance imaging : JMRI.

[24]  A Donner,et al.  Approaches to sample size estimation in the design of clinical trials--a review. , 1984, Statistics in medicine.

[25]  S. Drury.  Image interpretation in geology , 1987 .

[26]  K. Schilling,et al.  Sonographically guided directional vacuum-assisted breast biopsy using a handheld device. , 2001, AJR. American journal of roentgenology.

[27]  Aaron Fenster,et al.  A Mechanical, Three-Dimensional, Ultrasound-Guided Breast Biopsy Apparatus , 2001, MICCAI.

[28]  B. Fornage.  Sonographically guided needle biopsy of nonpalpable breast lesions , 1999, Journal of clinical ultrasound : JCU.

[29]  S. Tong,et al.  A three-dimensional ultrasound prostate imaging system. , 1996, Ultrasound in medicine & biology.

[30]  L. Liberman,et al.  US-guided core breast biopsy: use and cost-effectiveness. , 1998, Radiology.

[31]  T. King,et al.  Image-guided breast biopsy. , 2001, Seminars in surgical oncology.

[32]  T. Peters,et al.  Intraoperative US in interactive image-guided neurosurgery. , 1998, Radiographics : a review publication of the Radiological Society of North America, Inc.

[33]  J. Roelandt,et al.  Transseptal left heart catheterisation guided by intracardiac echocardiography , 2001, Heart.

[34]  D. Dershaw.  Equipment, technique, quality assurance, and accreditation for imaging-guided breast biopsy procedures. , 2000, Radiologic clinics of North America.

[35]  M D Schnall,et al.  MR imaging-guided localization and biopsy of breast lesions: initial experience. , 1994, Radiology.

[36]  S. Tong,et al.  Analysis of linear, area and volume distortion in 3D ultrasound imaging. , 1998, Ultrasound in medicine & biology.

[37]  S. Heywang-Köbrunner,et al.  MR-guided percutaneous excisional and incisional biopsy of breast lesions , 1999, European Radiology.