Ultrasound hybrid system holds promise for better breast screening

NeoVision plans 1995 release of 3-D MMF system

Mammography's position as the primary modality for breast screeningremains unchallenged, in spite of inroads into breast imagingbeing made by other technologies such as ultrasound and MRI. Mammographydoes have its drawbacks, however, one of which is the two-dimensionalnature of x-ray mammography films, which can obscure areas ofsuspicion.

One company working on improving the quality of breast screeningis NeoVision of Kirkland, WA. NeoVision is developing MammographyMedical Fusion (MMF), a unique 3-D imaging device that combinesmammography, breast sonography and real-time ultrasound-guidedneedle biopsy.

MMF is designed to address a common problem faced by mammographerstrying to correlate mammograms with ultrasound images. Patientswho show suspicious areas on mammograms are often required toundergo an ultrasound exam. However, since the patient is positioneddifferently for the two exams, suspicious areas are sometimesdifficult to locate with ultrasound, making correlation betweenmammographic and ultrasound orientation difficult to measure.

The MMF system consists of an ultrasound scanner that is integratedwith a customized mammography compression plate and frame, relievingthe need for a handheld transducer. NeoVision's plate replacesa standard mammography compression plate and attaches to a mammographyunit with the unit's interface pins, according to Steve Chernoff,director of external affairs at NeoVision.

The MMF system aims to overcome the difficulty of image correlationby providing depth data for each point on the mammogram. Duringa mammography exam, MMF's transducer automatically scans throughthe compression plate so that all dimensions of the breast areimaged. Once the x-ray exposure is taken, it takes about a minuteto conduct the ultrasound portion of the exam.

After the exam, the mammography film is developed and takento the reading room for diagnosis. If there is an area of suspicion,the film is digitized and the mammogram and ultrasound imagesare registered to each other via MMF's workstation. A complete3-D ultrasound data set is obtained from the digitized image fordisplay and comparison between the two modalities, telling mammographersthe depth of each point on the mammography film.

Other advantages of the hybrid system include:

** Patient recalls are eliminated, reducing time and costsfor diagnostic work-up;

** Images can be repeated easily and can be targeted to a particularregion of interest;

** Data regarding the lesion can be quantified for off-lineanalytical and research purposes; and

** Biopsies are easy to obtain, as real-time ultrasound guidanceis available.

An important aspect of marketing the MMF system is user training,Chernoff said. In particular, users need to be familiarized tothe 3-D data set provided by multiple scans.

NeoVision expects that the cost of its MMF system will be lessthan a stand-alone mammography unit or general-purpose ultrasoundsystem. The company plans to position the unit as an adjunct toa facility's existing mammography unit that can increase throughput,reduce costs and improve the quality of exams.

Although Chernoff said that the company is open to discussionwith other hardware and software manufacturers, nothing concretehas been initiated in terms of strategic alliances. Eventually,the company hopes to market its product internationally.

NeoVision plans to file a 510(k) application later this yearfor MMF as a diagnostic ultrasound device, and hopes to beginmarketing the system next year. MMF has undergone clinical testingat the University of Washington in Seattle.