Breast Imaging: Building Digital into Mammography

Breast imaging was big news at RSNA 2004. Much of the buzz focused on digital mammography technology. While the results of the Digital Mammographic Imaging Screening Trial (DMIST), a comparison of digital and film mammography in nearly 50,000 women, won't be available until spring 2005, interest in digital remains high - largely because of the potential for productivity gains.

There are some new digital systems and quite a few more in the works, but technologies to aid and facilitate the transition to digital mammography really stole the show. These include everything from multi-modality, multi-vendor workstations that allow users to read ultrasound, MRI and digital mammography images from a variety of systems and vendors, and feature integrated CAD capabilities to PACS optimized for mammography. Technologies that simplify the comparison of current digital mammograms to prior analogs were also big. And vendors were serving up more cost-effective digital options via CR-based systems and new analog systems that can be upgraded to digital to conquer the big price tag barrier of full-field digital mammography systems for many sites. CD creation systems to share digital mammograms and other patient information with clinicians as well as patients were also spotlighted.
   
And while mammography remains the workhorse of breast cancer screening and diagnosis, it benefits greatly from several adjuncts. Other options to complement mammography, discriminate benign form malignant findings and possibly detect breast cancer earlier are getting closer to the market. One of these, breast tomosynthesis, which has received a fair share of buzz in the last few years, could be on the market by RSNA 2005. Several other new breast-scanning technologies are also on the verge of FDA approval.   

Finally, a few vendors showcased new systems and features to simplify and improve the stereotactic breast biopsy process.

(Note: companies appear in alphabetical order.)

Agfa Corp. launched its new mammography diagnostic workstation, the IMPAX MA3000.

Designed to enhance the way digital mammography images are retrieved, displayed, archived and distributed, the IMPAX MA3000 mammography diagnostic display station is a multi-modality workstation that delivers 'one-stop' review and results distribution for all digital breast-imaging studies and supports complete access to other general imaging exams from a single workstation. The digital display station was developed based on Agfa's PACS model of information management; it includes PACS workflow features and tools with added specialized screening workflow and diagnostic tools, such as comparative review. Previous studies can be compared side-by-side to current images, allowing user and modality preferences for display, review and comparison of images to be defined for greater user flexibility. The IMPAX MA3000 mammography diagnostic workstation comes with full integration capability with PACS, RIS and HIS and reporting applications. When deployed as part of a PACS network, images can easily be retrieved and reviewed from anywhere on the network with other data.

Bioptics Corp. introduced the PiXaray plug-and-play digital mammography cassette that enables an upgrade from film-based to digital mammography. The cassette is based on a high-performance, flat-panel detector and high-resolution scintillator technologies. PiXaray is packaged as a standard mammography film cassette for a convenient and cost-efficient upgrade to digital mammography. The technology is available for investigational use only.

Cedara Software showcased its I-ReadMammo workstation and I-Acquire/MG mammography scanning console.

According to Cedara, I-Read Mammo eliminates the need to switch between workstations by supporting mammography systems from multiple vendors on a single workstation. The system also saves reading time by automating display and review of images from multiple modalities such as ultrasound and MRI and integrating CAD. I-Read Mammo integrates with Cedara's film digitizing application for viewing old film images with new digital images and it improves productivity by allowing radiologists to prescribe the image layout, presentation and view order.

Cedara's I-Acquire/MG mammography scanning console supports multiple mammography detectors, optimizes workflow by focusing the tech on a single console and facilitates image processing with image manipulation tools and proprietary enhancement technology. The system offers standard DICOM communication and optionally reads and writes files to CD. An optional CD viewer enables the creation of patient CDs with direct viewing capabilities. I-Acquire/MG enables OEMs and system integrators to create digital mammography systems that feature powerful workflow and image processing capabilities. The ready-to-integrate solution can reduce productization efforts and development costs resulting in faster time-to-market and return on investment, Cedara said.

Confirma, Inc. showcased the Access Breast Coil for breast MRI scanning.

The dual-purpose coil design provides greater access for breast MRI, the company said. Access' multi-channel design is optimized for parallel imaging; it maximizes diagnostic and interventional capabilities. Access features an open design for flexibility in interventional procedures with lateral, medial and cranial-caudal access. An integrated lighting system provides illumination for interventional guidance, and ergonomics are optimized for patient comfort. The Access Breast Coil will be available in the first half of 2005.

DatCard Systems, Inc. launched MammoSmart at RSNA 2004.
   
MammoSmart provides a patient with her complete mammography history and breast care information. It stores the information on an automatically produced CD-R/DVD-R. Each disc contains personal demographics, insurance information and medical history; self-breast/family healthcare history; digital mammograms and diagnostic results; customizable educational video capture; tools for further research through support group website links and other information on related topics and answers to frequently asked questions. The technology enables hospitals and imaging centers to improve patient communication, exceed MQSA patient education standards, market their facility, save on laser film costs and save on storage space, the company said. Facilities can customize any number of templates to meet patient needs with photos, images and high-definition video and add patient specific information from different medical technologies on the CD, update content on an ongoing basis and query retrieve or send DICOM information from the hospital network and record it to a CD/DVD. OEMs can embed their own DICOM viewer on MammoSmart, customize MammoSmart with individual branding and use MammoSmart to add value existing products. MammoSmart integrates with hospital registration, PACS and RIS/mammography systems.

Dobi Medical International, Inc. announced that it is in the fifth and final stage of the FDA approval process for its ComfortScan system.

ComfortScan detects tumor angiogenesis, or abnormal blood vessel growth, that characterizes malignancies. ComfortScan provides functional, dynamic imaging of tissue changes using light and a proprietary image-processing algorithm. Used in combination with mammography and ultrasound, the system should provide physicians with more complete information to help determine whether a tumor is malignant or benign, the company said. ComfortView Software is used for analysis of angiogenesis and assessment of breast disease. It enables a quick review and analysis of the dynamic images captured by the system. Color-mapped images indicate areas of increased vascularity, and a temporal graph measures the hemodynamic response of the region of interest to gentle external pressure over time. Images can be printed or digitally archived for future use and interpretation.

DR Systems highlighted the recent clearance of diagnostic reading of digital mammography to its PACS.

The diagnostic reading clearance facilitates integration of digital mammography into the RIS/PACS workflow to achieve efficiencies in automated reporting, storage, archiving and web-based distribution. DR Systems' capabilities for digital mammography include the ability to view, archive and retrieve previously digitized images; the ability to scan prior mammograms for comparison to current exams and streamlined comparison to ultrasound, MRI and other breast imaging studies. The capabilities are available via DR Systems Release 6 software using the Dominator Diagnostic Workstation. Other features include comparison to ultrasound MRI and other modalities, automated reporting and CD, internet and web distribution of images, audio and reports.

Eastman Kodak Co. launched a mammography upgrade for its Kodak DirectView PACS system 5 and highlighted several mammography works-in-progress.

The PACS upgrade allows users to integrate digital mammography with general radiology workflow and review and store ultrasound, MRI and other digital modality images. It includes a Mammography Workstation with multi-modality, multi-vendor support. The Mammography Upgrade and Mammography Workstation will be available in the first quarter of 2005.

The works-in-progress includes a mammography module for its RIS platform that optimizes mammography-specific reporting and tracking requirements, 50-micron image scanning with specialized screens and cassettes, a CAD application on digital mammography systems and integration of CAD and speech commands into the Kodak PACS System 5 Mammography Upgrade.  

Emageon at RSNA announced FDA clearance for softcopy viewing of digital mammography for its UltraVisual advanced visualization software used in conjunction with FDA-approved display hardware.

Presentation-quality mammography images and prior digitized mammography film images can be displayed using features that are native to Emageon's software. Standard tools include real-time pan/zoom with zoom presets; intuitive selection of current and prior images with customizable hanging protocols; a fully configurable magnifying glass; comprehensive grayscale support with window/level presets; arbitrary image rotation; image filtering; key-image creation for communicating with other physicians and multiple display support. All settings are configurable and follow the user throughout the enterprise.

Fischer Imaging Corp. launched its SenoScan 2 full-field digital mammography system, highlighted new features on its stereotactic table, showcased the I-ReadMammo SenoView and shared research demonstrating decreased recalls with digital mammography and a collaborative arrangement with InSightOne. The company also showed two works-in-progress.

Fischer's SenoScan2 FFDM system offers both 50 and 25-micron native diagnostic resolution, reduced radiation dose and virtual elimination of motion artifacts. The new system provides enhanced functionality for technologists and enhanced workflow for radiologists. Improvements include automatic exposure control and image processing capabilities at the acquisition station to enable export of processed DICOM images to the hospital network.

Fischer's stereotactic table incorporates a new breast cancer brachytherapy capability with a grid mechanism for catheter positioning.

The company also shared a study showing that the use of digital mammography reduced recall rates by 40 percent compared to film. The prospective study involved 11,058 screening mammograms at Sarasota Memorial Hospital Breast Center with 4.1 of film screened patients recalled compared to 2.4 percent recalled after SenoScan digital mammograms. Furthermore, in digital cases that were recommended for biopsies, the radiologist was able to make final diagnostic determination without further imaging in more than 90 percent of cases.

Fischer also showed the customized version of Cedara's I-ReadMammo software integrated with SenoScan. The I-ReadMammo SenoView is a dedicated mammography softcopy workstation. SenoView Plus provides multi-modality image display and review to allow radiologists to compare SenoScan digital images with ultrasound, nuclear medicine and MRIs for improved workflow and reading efficiency.

Fischer and InSiteOne announced collaboration to provide customers with Fischer digital mammography integrated with InSiteOne Storage Services to enhance productivity and patient care.

Fischer works-in-progress include an FDA cleared film digitizer that will be available in early 2005. The digitizer will enable softcopy reading of prior mammograms for comparison. The company also showed a prototype integrating ultrasound and digital mammography.

Fujifilm Medical Systems USA Inc. launched the Synapse Multi-modality Breast Imaging Workstation and showed Fuji CR for Mammography (FCRm) as a works in progress.

The Synapse workstation displays any full-field digital exam for analysis and interpretation and also displays related MR and ultrasound studies. Fuji's Synapse workstation configuration can be used as a full-featured diagnostic workstation for any imaging exam. It incorporates dual, high-brightness, 5 megapixel, flat-panel monitors with an optional third, 20-inch color LCD monitor for productivity applications and viewing of color images. Diagnostic tools include image pre-sets, window/level, pan, zoom, annotation and magnification as well as Fuji's patent-pending Reading Protocol technology, which automates presentation of documents, image processing parameters and results.
   
FCRm features ClearView-CSm, a four-cassette multi-plate reader with dual-side reading technology and 50-micron pixel sampling. FCRm provides the benefits of digital for the cost of a single system and is compatible with existing mammography imaging units, with the CR cassettes replacing analog film cassettes. The reader will be used with Pattern Enhancement for Mammography (PEM), Fuji's advanced image processing tool. FCRm and PEM are not yet available in the U.S. FDA approval is anticipated in early 2005.

GE Healthcare showcased its Senographe DS and unveiled a few works in progress.

According to GE, the Senographe DS full-field digital mammography system is  designed to meet all the clinical needs from screening, diagnostic to interventional procedures, using the same detector to optimize image quality and workflow. The system has a patient-centric design and intuitive controls that allow the technologist who performs the exam to focus on her patient and makes the mammography exam an easier and more comfortable experience. The stereotaxy option for breast biopsies on the Senographe DS is a cost-effective alternative to a dedicated interventional room. It enables technologists to quickly transition from initial screening applications to diagnostics, and, if needed, to interventional procedures, all in one room. Biopsies can be performed on the same dedicated gantry with better access to lesions.

The Senographe DS and Seno Advantage multi-modality breast imaging workstation are cornerstones of GE's Breastcare Essentials, a complete imaging and information management solution to help healthcare professionals detect breast cancer earlier and treat it more effectively. Designed with the future in mind, the Senographe DS system can serve as the platform for many advanced applications currently under development such as Tomosynthesis (3D breast imaging). Tomosynthesis, imaging fusion of FFDM and ultrasound and contrast media mammography are advanced applications aimed to leverage the potential of digital mammography to facilitate the earliest detection of breast cancer, thereby giving a woman the best potential clinical outcome through early treatment, GE said.

GE's works in progress for mammography included a 3D mammography workstation, a new-generation detector to optimize performance for advanced applications and a tomosynthesis system. The workstation and tomosynthesis system will undergo clinical evaluation in 2005.

Hologic, Inc. highlighted at RSNA the August 2004 FDA clearance of SecurViewDX breast imaging workstation, shared its "vision" for workstations of the future, showcased the Lorad Selenia, outlined a new agreement with iCAD and unveiled breast tomosynthesis technology.

SecurView_DX is a dedicated, multi-modality workstation for display and interpretation of any screening or diagnostic digital mammogram, as well as MRI, CT, PET and ultrasound images. The workstation also supports CAD programs. SecurView_DX allows users to view digital mammograms from any vendor and images from other modalities. This will boost workflow for imaging centers since physicians no longer have to view images from different vendor's systems on vendor-specific workstations, Hologic said. Physicians also can use Hologic's package of image manipulation tools on virtually any digital mammogram.
 
The Lorad Selenia incorporates a direct conversion detector to preserve image sharpness by completely eliminating light diffusion. The large 24 x 29 cm active image area accommodates most breast sizes with a single exposure, and a 70-micron pixel size for imaging microcalcifications at the earliest stage of formation. Other features include a High Transmission Cellular (HTC) Grid to significantly reduce radiation scatter for higher contrast images and Smart Paddle System to allow accurate, easy positioning of all breast sizes. Finally, the custom-designed Softcopy Workstation streamlines workflow and provides flexible user configurability.

Hologic's "workstation of the future" provides multi-modality image viewing, the ability to show cine loop or static tomosynthesis images, offers a touch screen with color monitor and easy graphical user interface to ease information entry and reduce keystroke and potential errors, and separate high-resolution monitors for viewing images. Hologic said it will likely be a year or more before the vision becomes commercial reality.  
   
Hologic said its private label agreement with iCAD Inc. covers the production and marketing of film-based CAD systems. Under the agreement, iCAD will manufacture film-based CAD systems for Hologic targeted to serve lower case-volume mammography clinics.
   
Hologic also highlighted its work in breast tomosynthesis. Tomosynthesis requires adjustments to mammography systems to create 3D images based on the acquisition of multiple images of a stationary, compressed breast taken at different angles during a short scan. The company believes that digital breast tomosynthesis will reduce patient recall rates as it reduces uncertainty stemming from tissue overlap. The biopsy rate also could be decreased because of improved visualization, especially in dense breasts. Hologic demonstrated tomosynthesis with patient images and a prototype add-on to Selenia at RSNA 2003; clinical trials began this summer.

Imaging Diagnostic Systems, Inc. debuted its CT Laser Mammography System (CTLM) as a works in progress.

CTLM uses a laser for noninvasive breast imaging. The technique images blood hemoglobin and neoangiogenesis, or new blood vessel formation, which is usually associated with breast cancer. The company's vision is for CTLM to be used in conjunction with x-ray and ultrasound to assist in differentiating malignant from benign lesions and help reduce the number of invasive biopsies performed that later prove to be negative. The target patient population includes women with equivocal mammographic findings within ACR BI-RADS categories 3 or 4. The company believes that laser optical breast scanning could become a primary method of diagnostic imaging and following response to therapy. Imaging Diagnostic Systems plans to re-submit CTLM for pre-market approval in early 2005.

Insight Healthcare Information Systems launched OmniCare version 7.0 software.

According to the company, the new version's workflow/worklist module can help healthcare facilities go paperless. Features include front desk registration, exam order entry, worklists for technologists and radiologists, printing of exam requisitions, labels, flash cards and questionnaires and integration with order entry, financial systems and digital dictation. OmniCare 7.0 also provides one-touch reporting with voice recognition, electronic file room management, patient scheduling, PACS, CAD and HIS interfacing, paperless worklists, a women's health module and case management for extended cases.

MammoBase debuted the Interventional Breast Tracking (IBT) system.

The system is designed to pick up where mammo tracking leaves off. It provides interventional procedure tracking and monitoring of outcomes, pathology and complications as well as CPT/ICD9 coding by procedure. IBT analyzes outstanding pathology and automatically tracks pathology outcomes. It creates statistical reports for complications and pathologies and tracks biopsy procedures. The system can track multiple nodules within the same breast individually, follow complications and provide MRI breast tracking. It also offers a second look at accurate billing.

Mammography Reporting Systems showed the beta version of its Mammography reporting System 6.4.

New features include MRI and ultrasound BI-RADS and email capabilities for patient and clinician correspondence. The new version should be available by the end of the first quarter 2005. The MRS system generates the radiologist's exam report and an automatically selected lay-language patient result letter. It also tracks problem cases, generates follow-up letters and provides medical audit and practice management features. Other features include a user-definable, One-Touch exam reporting template system that incorporates as few or as many decisions as the radiologist prefers. This saves time by allowing One-Touch reporting for negative or near negative cases as well as streamlining reporting for more serious cases. RIS, HIS, DICOM, digital workstations, voice recognition and scheduling interfaces allow integration. Data can be entered via keyboard, mouse, stylus or touch screen from either wired or wireless computing devices. The system also is compatible with a tablet PC. Barcodes can speed selection of patients and procedures. The MRS system can meet the needs of all types of facilities from small clinics to breast imaging centers to multi-site enterprises in a single integrated system, with special design considerations to support multi-site environments. These include a single database with site flexibility for multiple sites, multiple HL7 interfaces to accommodate communication with more than one RIS and multiple CAD interfaces to accommodate organizations with more than one brand of CAD. The system supports centralization of certain functions, such as letter generation and distribution and image interpretation. Statistical reports can be generated for the entire organization or any subset.

Philips Medical Systems highlighted EasyVision Mammo Mammography Viewing and reporting station and showed a works in progress MammoDiagnost CR mammography systems and the MammoDiagnost FD Eleva full-field digital mammography unit.

EasyVision Mammo is designed for high-volume, multi-modality viewing. EasyVision Mammo provides instant access to all breast images and offers multi-modality viewing with abundant image-processing tools that enable radiologists to magnify and enhance small details and dense areas for faster and easier diagnosis. The ability to analyze mammography data alongside ultrasound and MR images improves investigative and diagnostic possibilities, Philips said.

The company's mammography works in progress include the MammoDiagnost, which will be available as a conventional system with an upgrade to digital with CR, and the MammoDiagnost FD Eleva full-field digital mammography system. The MammoDiagnost and PCR CosimaX combine for an economic CR-based digital option, Philips said. MammoDiagnost is a universal mammography system for screening, diagnosis and biopsy. It provides an ergonomic design, motorized iso-centric rotation table, automatic exposure control and inverted 180-degree rotation. The full-field Eleva provides 50-micron screening resolution and 25-micron diagnostic resolution. The system uses direct digital detector technology and offers low-dose, flat-detector technology and automatic exposure control. It also features a large detector to accommodate any breast size. The systems have not yet received FDA approval. U.S. availability of the MammoDiagnost systems is anticipated late 2005 or early 2006.

Planmed at RSNA debuted its Planmed Nuance Classic and showcased the Nuance full-field digital mammography system.

The Nuance system provides features to enhance performance and versatility. For example, the MaxView Breast Positioning System draws more tissue into the field of view, maximizing the amount of breast tissue visualized by radiologists. The system features 48-sensor Flex-AEC anatomically adaptable exposure system. According to Planmed, Flex-AEC reduces retakes while optimizing image quality The Nuance Classic also provides internal readiness for bridging to full-field digital technology. The system is designed for future upgradeability on-site to the Nuance full field digital mammography system.  

The Nuance digital system approach will offer two detector sizes for direct digital capture amorphous selenium technology. A one-piece magnification tower provides multiple imaging possibilities. An optional DigiGuide system provides needle guidance for stereotactic breast biopsy. Nuance also provides comprehensive DICOM compatibility for fast communication via hospital network.

The FDA approved analog system will be available for sale in early January 2005 and the digital Nuance is a work in progress.

R2 Technology, Inc. showcased its DigitalNow software and showed an R2/Sectra mini-PACS for mammography.

DigitalNow serves as an archiving enabler to help prepare for the transition to digital mammography. DigitalNow is designed for mammography practices that are preparing to transition from film to digital and want to transition seamlessly to soft-copy reading. The software improves the digital reading environment and workflow by eliminating the need for lightboxes next to high-resolution monitors. It features universal compatibility with all DICOM workstations and flexible electronic patient data system integration.

The mini-PACS offers storage capacity for up to 150,000 images and will be available in the second quarter of 2005.

Sectra showed its Sectra MicroDose Mammography system, FDA-cleared breast imaging workstation and Sectra PACS for Breast Imaging. The company also debuted a system that marries osteoporosis testing and mammography.

The digital mammography system embraces a low-dose concept to provide reductions in radiation doses. The Sectra MicroDose Mammography system supports the entire workflow from exam to documented diagnosis. The ergonomic system provides high throughput and customized workflow. It incorporates new digital detector technology that counts each individual x-ray photon to provide reduced radiation dose without compromising image quality. A 'scan technique' reduces scattered radiation to a minimum. As a result, the radiation dose for four images obtained using the system is often lower than the dose for one image obtained using traditional film screen technology, the company said. The Sectra MicroDose is not yet available in the U.S. The company anticipates FDA approval by the end of 2005.

Sectra's new workstation extends its IDS5 workstation family to meet the demanding workflow requirements of full-field digital mammography, providing breast imaging specialists with true multi-modality capability, the company said. The workstation supports CAD from R2 using the CSN (Clinical Solutions Network) framework, according to Sectra.

Sectra PACS for Breast Imaging is based on the company's general PACS but adapted for mammography use. The system can be customized for individual users to automatically present preferred function image settings. The PACS can facilitate and automate double-reading workflow, and it automates retrieval of old images. Finally, radiologists can review multi-modality, multi-vendor images on a single workstation with Sectra PACS for Breast Imaging.

The digital Sectra MicroDose Mammography system has been integrated with the Sectra Digital X-ray Radiogrammetry (DXR) technology. This combination allows a hand x-ray for osteoporosis testing to be acquired during a mammography exam. The Digital X-ray Radiogrammetry unit has gained FDA clearance, but the MicroDose unit has not.

Siemens Medical Solutions showcased its Mammomat Novation^DR digital mammography system and unveiled a syngo breast imaging imaging work-in-progress.

The Mammomat Novation^DR gained FDA pre-market approval in August 2004. The full-field digital mammography system provides digital screening, diagnosis and stereotactic biopsy capabilities in one system. It features a flat-panel detector based on amorphous Selenium (aSe) detector technology. This technology enables a direct conversion of x-rays to digital information. The aSe detector technology has the potential to provide higher spatial resolution and greater clinical detail, the company said. The 24-by-29 centimeter image detector size also enables imaging of a larger range of patient sizes, and the system features a new paddle designed for easier and more comfortable patient positioning. The system features MammoReport^Plus, a dedicated works