Breast Imaging
Breast imagers certainly had their fair share of new solutions to examine at RSNA this year. Visitors peeked at a number of full-field digital mammography systems - and gained some new insight into clinical and practice management advice when it comes to digital mammography and often integrating analog images into workflow, too. Many vendors expect digital system sales to rise now that the Digital Mammographic Imaging Screening Trial (DMIST) results are out and as analog systems age. Other vendors touted more economical CR mammo works-in-progress, which could give digital a run for the money, particularly in lower volume sites. Other highlights were multiple breast tomosynthesis works-in-progress and new breast imaging techniques designed to complement mammography.

Agfa Healthcare shared with RSNA goers its works in progress CR Mammography 85.0.
The system is designed to address the cost issue that prevents lower volume providers from implementing digital mammography and the needs of sites with backlogs and/or aging mammography equipment. The company says it has started clinical trials for the FDA approval process.

Aurora Imaging Technology, Inc. launched the Aurora 1.5T Dedicated Breast MRI System with UltraRODEO Plus fat and normal ductal tissue suppression technique, AuroraCAD integrated diagnostic software, Aurora SUPERSHIM and fully integrated MRI-guided AuroraBIOPSY functionality.  
The Aurora device utilizes a specialized breast-coil design that provides an elliptical "sweet spot" to image both breasts, chest wall and axillae in a single bilateral scan, without compromise in image contrast or resolution. The continuous, homogeneous image is optimal for evaluation of both breasts, Aurora says. The device offers 1mm slices to deliver consistently high image quality.
Aurora provides biopsy functionality that accommodates all existing vacuum-assisted biopsy manufacturers, proprietary RODEO which is an established fat and normal ductal tissue suppression technique and integrated AuroraCAD software that allows for improved diagnostic and screening capabilities.  
Utilizing new UltraRODEO Plus technology, the Aurora 1.5T Dedicated Breast MRI System provides specialized pulse sequences fine-tuned to suppress breast fat and normal ductal tissue. This minimizes the water and protein hot spots that can complicate MRI images. The technology also provides more detail about lesion distance, length/width, surface area and volume, enhancing the specificity of diagnosis and treatment.
AuroraSUPERSHIM is a shimming technology specifically developed for breast imaging. The process provides additional fat suppression to boost image quality, reduces hot spots and enables visualization of the axillae along with both breasts. This technology also streamlines data acquisition to reduce patient scan time.  
AuroraCAD is an integrated advanced-image acquisition, processing and analysis software application. During acquisition, the software automatically recognizes and compensates for patient motion artifacts and distortions. The image analysis and processing component provides automatic, simultaneous display of multiple image views, as well as advanced 3D processing including MPR and MIP.
The Aurora 1.5T Dedicated Breast MRI System offers fully integrated interventional functionality and a wider aperture for the largest access area to the breasts for MRI-guided biopsies. The unit accommodates both core and vacuum-assisted devices and enables biopsy of multiple sites during a single procedure.
The system features a massage-type table design contoured for the female anatomy to enhance patient comfort and reduce motion artifacts. Patients enter feet first to minimize claustrophobic reactions. The 64cm gantry accommodates women up to 500 pounds and can image women with up to and including a G-cup bra size.

CompuMed, Inc. highlighted a licensing agreement with FUJIFILM Medical Systems USA.
Fuji will integrate CompuMed's OsteoGram osteoporosis screening software with its CR systems as well as future CR mammography systems. Fuji CR for Mammography (FCRm) requires FDA approval, is pending PMA review and is not yet commercially available in the U.S. Under the terms of the five year agreement, Fuji will place an initial order for 10 OsteoGram systems and then license and distribute the OsteoGram on existing and new CR systems and on future CR mammography platforms in the U.S.

Dilon Technologies Inc. showcased the DILON 6800 Gamma Camera that employs breast-specific gamma imaging, a functional imaging technique that has proven to be effective in early detection of breast cancer and in the differentiation of malignant and benign tumors, the company says. The high-resolution, compact detector captures tumor information by viewing the metabolism of cancerous lesions in the breast via radiopharmaceutical uptake.  

DOBI Medical International highlighted its ComfortScan system that is designed to identify abnormal blood vessel growth, or tumor angiogenesis - a key indicator often associated with breast cancer. The hardware and software system uses light-emitting diodes (LEDs) and gentle external pressure to highlight angiogenesis in the breast, with less than one-minute scanning time. The test is noninvasive, involves no x-ray radiation, is all digital and comfortable to the patient.
Unlike mammography, which provides a static snapshot of physical details within the breast at a single point in time, the ComfortScan system is intended to deliver functional, dynamic images of vascular changes occurring within the breast, DOBI says. Another way of looking at it is to say the ComfortScan is a physiological view of the breast as an alternative to the anatomical view provide by mammography. Thus, in combination with mammography, the ComfortScan system is expected to provide physicians with more complete information to help them determine whether a tumor is malignant or benign. This added diagnostic tool is expected to be especially valuable for women under 50-year-old where mammography is less effective, according to DOBI.
The ComfortScan system is currently in the fifth phase of its Pre-Market Approval application (PMA) process with the FDA.

Fuji Photo Film Co., Ltd., the parent company of Fujifilm Medical Systems USA, introduced a single plate CR mammography reader that is expected to be available in the first quarter of 2006. U.S. FDA approval for marketing is pending.

The reader enables mammography facilities outside of the U.S. deploying the Fuji Computed Radiography for mammography (FCRm) technology to choose single plate or multi-plate reader(s) depending on their specific workflow and throughput needs.
FCR PROFECT ONE offers flexibility in how Fuji's digital mammography technology can be installed. Facilities can consider installing an individual CR reader in each mammography exam room. FCR PROFECT ONE provides 18x24 cm and 24x30 cm field-of-view, as well as the ability to perform mammography, general radiography and pediatric imaging exams. The FCR PROFECT ONE will be available outside the U.S. in the first quarter 2006.
FCR ClearView-1 and FCR ClearView-CS are capable of reading general x-ray and pediatric imaging, and will be upgraded for mammography application upon FDA approval.

GE Healthcare introduced three new advanced imaging technologies across different modalities to enhance breast cancer detection: MR BREASE (breast spectroscopic examination), a new technique using spectroscopy to improve specificity; a new collaborative agreement with Johnson & Johnson's Ethicon Endo-surgery to integrate biopsy and portable ultrasound technologies; and a new digital mammography workflow module for GE's Centricity PACS. The company also highlighted its Personalized Breast Cancer Management, the Senographe DS and Senographe Essential, a work-in-progress.
Breast magnetic resonance provides high sensitivity and is a rapidly growing modality in breast imaging. It is being used as an imaging tool for high-risk patients and as a problem-solving tool for patients with dense breasts and indeterminate mammograms. Also, breast MR is used to define the extent of disease by looking at chemical makeup with breast spectroscopy. GE's MR application BREASE improves the ability to distinguish benign breast lesions from cancerous ones by showing elevated concentrations of choline, a product of membrane synthesis that surges in rapidly reproducing cancer cells and is a strong indicator of malignancy. BREASE potentially reduces the number of benign biopsies indicated by MR (according to Robert Lenkinski, PhD, head of MRI research at Beth Israel Deaconess Medical Center in Boston).
GE's MR BREASE is a new enhancement to the company's VIBRANT (volume imaging for breast assessment) high definition technology that enables a non-invasive imaging procedure of both breasts simultaneously, in a single patient visit. VIBRANT-XV further expands the capability to acquire high-resolution images at high speed, providing both exquisite anatomical detail as well as critical kinetic information.
Through GE's collaboration with CAD provider Confirma, GE distributes CADstream technology to MR customers worldwide. CADstream enhances the clinical efficacy of breast MR studies by highlighting and color-coding areas indicative of breast cancer for further review and automatically correcting MR images for patient movement. Working together, VIBRANT and CADstream can reduce processing and interpretation time to a maximum of 10 minutes, while helping to improve the quality of breast MRI programs. A new, GE-customized CADstream application provides physicians with more flexibility to access images over multiple platforms (operator console, Advantage Workstation, or Linux PC).  CADStream HDx 4.1 also includes enhancements to MR biopsy guidance.
GE and Ethicon Endo-Surgery, Inc. announced a collaborative sales and marketing agreement to help launch a new solution that could reduce the number of open surgical breast biopsies performed each year. Ethicon Endo-Surgery and GE will offer compatible products that can operate together as part of an integrated biopsy system to help enable breast surgeons to provide a less invasive, more accurate method of diagnosing breast cancer compared to open surgical biopsy. The companies will promote two technologies working in tandem: the Ethicon Endo-Surgery Mammotome EX Biopsy System and the GE LOGIQ Book XP compact ultrasound system. When used together, these technologies give patients and surgeons immediate access to a highly accurate diagnostic procedure for patients undergoing breast biopsy.
GE's Personalized Breast Cancer Management provides physicians with the tools to develop:
  • A comprehensive end-to-end breast cancer protocol that tailors screening, the latest technology diagnostic tests and treatments according to individual risk factors and pathology.
  • An operational excellence and integrated multi-specialty care coordination and optimization program that significantly reduces the cycle time from detection to diagnosis and treatment.
Senographe DS is designed to meet all clinical needs, from screening to diagnostic and interventional procedures, using the same detector to optimize image quality and workflow. Senographe DS and Seno Advantage multi-modality breast imaging workstation are the cornerstones of GE's digital mammography offering. Version 2.0 of Senographe software provides very advanced hanging protocols, CCOW integration and a RIS interface to sync patients in high throughput sites.  
GE also shared Senographe Essential. The next-generation 24 x 30.7 cm detector plate was submitted for FDA approval in May 2005. The high-throughput solution is designed for standard 2D digital mammography and tomosynthesis.

Hologic, Inc. demonstrated at RSNA its Selenia workflow solutions for healthcare professionals, highlighted its new Skeletal Health line and shared some works-in-progress, namely in breast tomosynthesis.
This year Selenia incorporates several new features including the ability to share information between technologists and radiologists; multi-modality solutions allowing radiologists to review DICOM breast images from other diagnostic modalities simultaneously; image management solutions that provide high-volume, short-term storage of mammography studies and seamless archival integration with existing PACS and image analysis and manipulation tools including intelligent roaming and customizable image layout and orientation formats.
Hologic Skeletal Health products build on the company's presence in the bone density and Fluoroscan C-arm business. The recently announced distribution and service agreement with Esaote to sell and service Esaote's line of extremity MRI systems builds on the existing organization.
Another Hologic skeletal health product is InSight, a mini C-arm X-ray system. InSight is designed to help orthopedic surgeons perform minimally invasive surgical procedures of the extremities, as well as for low-dose, in-office imaging procedures.
The company touted its strategic research collaboration with The Johns Hopkins University (JHU) for the development of tomographic 3-D image reconstruction of the hip utilizing Hologic's Discovery line of bone densitometers. While two dimensional bone mineral density is recognized as a strong predictor of fracture risk, it is increasingly understood that bone structure is also an important contributor to overall bone strength. The accurate assessment of complex femur structure requires a three dimensional volumetric density model. Hologic's Discovery technology exploits patented rotating C-arm capability to acquire multiple views of the femur at different angles. The collaboration with Johns Hopkins utilizes this low dose acquisition to construct a 3D volumetric model of the femur.
Hologic also shared its latest idea of what a breast tomosynthesis system should look like and presented the results of ongoing trials to demonstrate the improved sensitivity and specificity of digital breast tomosynthesis compared to 2D digital mammography.
Hologic also previewed its workstation of the future concept. The workstation displays both digital mammograms and tomo images and features a touchscreen display.

i3ARCHIVE, Inc. and IBM launched MyNDMA, a personal health management tool linked directly to i3's National Digital Medical Archive (NDMA) digital mammography archive.
MyNDMA provides women access to and control of their own electronic health records by managing their personal medical records such as digital mammograms and diagnostic test results. Secure storage of personal mammography images and data provide women with the ability to proactively monitor their personal health over time and access records when visiting a new doctor or obtaining a second opinion.
With patient consent, individual images and data can be made available to physicians and researchers. The system is powered by IBM's grid computing and DB2 technology to allow researchers to search the archive on demand, giving them immediate access to the critical data needed to identify breast cancer patients for clinical trials in less than a day.     

Imaging Diagnostic Systems, Inc. featured the CT Laser Mammography System (CTLM), a breast imaging system that utilizes laser technology and patented algorithms to create 3D cross-sectional images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. The company is seeking PreMarket Approval (PMA) from the FDA for the system to be used as an adjunct to mammography.

Kodak's Health Group showed digital image capture systems for mammography exams and debuted enhancements to its RIS and PACS platforms for mammography.
The KODAK DIRECTVIEW CR Mammography Feature for CR 850, CR 950 and CR 975 Systems is intended to offer the ability to produce mammography images using KODAK DIRECTVIEW CR Mammography Cassettes and new EHR-M screens. This optional feature can enable healthcare facilities to perform general radiography and mammography exams on the same CR platform and allow them to upgrade or retrofit existing KODAK CR systems for the use in mammography. Kodak's CR mammography feature is intended to offer 50 micron image scanning with specialized screens and cassettes. These durable CR cassettes are designed for long life to reduce operational costs, while special pink labeling of the cassettes will make for easy identification by medical staff.
CR offers a practical entry into digital mammography, Kodak says. Clinical trials are underway and Kodak has begun the pre-market submission process with the FDA.
The company also shared the KODAK Point-of-Care CR 300M System for Mammography. The works-in-progress is a compact, dedicated tabletop CR system for mammography applications.
New mammography specific features for Kodak's CARESTREAM RIS platform include automatic generation of patient letters and pending requests for annual recalls and a mammography information drawing tool with annotation capability. The KODAK CARESTREAM PACS now supports storing of original images and a single secondary capture image containing CAD markers for some digital CAD systems and support for additional mixed color and resolution monitor displays.
Kodak also showed as a works-in-progress automatic justification of different mammographic views, tissue inversion and the integration of Confirma's CADstream with Kodak's CARESTREAM PACS platform. This integration will enhance radiologists' productivity by providing the ability to view CAD results for breast MRI exams from diagnostic workstations.
Kodak also shared a work in progress mammography workstation. The multi-modality, multi-vendor workstation features the same user interface as CARESTREAM PACS. The configurable system can support up to four five megapixel monitors including an optional color monitor.

MagView unveiled Version 5.3 for MagView Information Systems Reporting and Tracking.
The newest version incorporates many suggestions from MagView users, changes to improve HIPAA compliance and many new features. The system provides expanded interface capability to include interfaces to digital mammography workstations from Hologic, GE and others to improve the workflow, structured reporting templates for breast MRI and bone density, expanded capability to add additional findings notes and edit final reports prior to signing and releasing, surgical pathology tracking to track and correlate performance of biopsy results, expanded capability to collect more comprehensive patient history and expanded capability for custom patient notification and recall letters. It also meets the latest requirements and recommendations for compliance with ACR BI-RADS and MQSA and adds procedure specific grouping of macros for faster reporting.

Mammography Reporting System Inc. at RSNA highlighted its MRS mammography reporting and tracking systems.
MRS facilitates a totally paperless environment. Various connectivity options eliminate the paper trail from the patient to the technologist to the radiologist. Its highly scalable Microsoft SQL Server solution allows for connectivity with multiple vendor products across the enterprise.
MRS supports having the patient input her breast surgical history, risk factors and hormone use via a tablet PC or kiosk. The data are sent directly into the MRS patient history database. The technologist verifies or edits the patient history on the digital workstation or PC and puts the exam into the Wait for Findings list. When the radiologist accesses the patient images from the worklist on the digital workstation, patient history in MRS is automatically displayed. The radiologist can then generate the exam report in MRS via One-Touch Templates using touch screen or mouse and/or integrated voice recognition. The report is then sent to the RIS and or PACS/EMR.

PenRad Technologies, Inc. introduced PenVoice that extends the company's tap-on, tap-off, auto-negative and auto-clone technology. It incorporates audio feedback of key exam information to the radiologist and responds to spoken key words to generate or alter the narrative report while the radiologist interprets the negative exam to provide a hands-free, heads-up environment. The system is 100 percent focused on PenRad's mammography keywords. Selected spoken keywords are echoed back as acknowledgement for additional assurance. Keywords command PenRad's macro system for accurate report generation. PenVoice is currently available.  
The company also announced that it will release a complete software upgrade in the first quarter of 2006.

Philips Medical Systems at RSNA highlighted CR-based PCR Eleva digital mammography system that provides 50 microns/10 line pairs and can image 20 patients an hour. The system has been sold in Europe for 10 years. The company is working toward FDA clearance in the U.S.

Planmed showcased its Nuance Classic analog mammography unit and Planmed Nuance full field digital mammography system.
The Nuance Classic is designed to accommodate future upgrades to either CR-mammography or digital mammography. The system offers a technologist-focused ergonomic design. Flex Automatic Exposure Control (Flex-AEC) anatomically adapts exposure control. Optimal exposure values are calculated by utilizing all 48 detectors and Planmed's Flex-algorithm, with no need for the technologist to select the appropriate AEC chamber. Nuance Classic software facilitates an interface to a CR reader, and additional software optimizes image quality for CR acquired images. The optional MaxView Breast Positioning System facilitates breast positioning and maximizes the amount of visible breast tissue seen on the mammogram by using gentle traction to capture and draw more tissue into the field of view. Optional Side Access Positioning uses dedicated control buttons to drive the C-arm 30 degrees aside between different position angles. This increases open workspace, making patient positioning easier and more precise, the company says.
The Planmed Nuance full field digital system for screening and diagnostic mammography is fully DICOM compatible with unlimited PACS connectivity. It offers a conservative footprint, requiring only minimum space in the facility. According to Planmed, it has completed patient accrual in the U.S, and FDA clearance is pending. The company said it hopes to sell Planmed Nuance in the U.S. by the third quarter of 2006.

The unit features a precision amorphous selenium detector, integrated MaxView Breast Positioning System and two detector sizes. It is upgradeable to stereotactic breast biopsy and designed for advanced applications. The acquisition workstation offers modality work list, QC and image viewing tools. The review workstation offers Nuance SoftView Review Software, customizable workflow, DigiPad shortcut keypad for faster review and optional multi-modality support and CAD connectivity.

Sectra at RSNA showcased MicroDose Mammography and Sectra PACS.
In Europe, Sectra's Microdose Mammography is in full clinical operation, maximizing image quality, increasing throughput and minimizing radiation exposure. Sectra's breast imaging solution is a complete system comprising Sectra MicroDose Mammography stand and Breast Imaging PACS. The low dose FFDM system is optimized for high-volume screening with an efficient and ergonomic workflow. To highlight optimized workflow Sectra showed a case from registration through examination and documented diagnosis. Sectra MicroDose is currently in the FDA trials in the U.S.
Sectra PACS includes a multi-modality workstation designed for optimal reviewing of digital breast images from all vendors. It also features fast image display, large storage capacity, double reading and a special keypad for an enhanced workflow.

Siemens Medical Solutions presented its prototype digital breast tomosynthesis (tomo) system and showcased the NovationDR system.
The protoype tomo system, developed in close collaboration with Duke University Medical Center, is based on Siemens' Mammomat NovationDR full-field digital mammography system. It is being investigated in preliminary clinical trials for the detection of subtle mass lesions often undetectable by conventional mammography. The new prototype employs a Mammomat NovationDR system modified with a motorized x-ray tube to acquire image projections of the breast from many different angles, as well as a digital detector for increased speed and high quality image acquisition. Preliminary results conducted at Duke with several mastectomy and other patient cases suggest that the new tomo system is able to detect subtle mass lesions otherwise difficult to pick up with standard mammography, the company says. When fully developed, this new solution is expected to further enhance diagnostic ability by improving sensitivity of breast cancer detection, and more importantly, increase workflow by reducing false positives/misdiagnosis and unnecessary biopsies. The Siemens tomo system offers a large field-of-view enabled by a large area detector, which makes the prototype suitable for nearly all breast sizes. It has the potential to provide high sensitivity and specificity, which could allow radiologists to detect and characterize suspicious lesions more precisely. With low-dose 3D mammography, it may eliminate normal tissue overlap, which might otherwise obscure lesions. Additionally, enhanced visibility to view masses may be made possible with high contrast resolution.

"If digital breast tomosynthesis fulfills its promise of providing the unusual combination of greater sensitivity coupled with greater specificity and improved patient comfort, it may rapidly replace routine 2D mammography in the screening setting," said Jay Baker, MD, chief, Division of Breast Imaging, Department of Radiology, Duke University Medical Center. "While careful clinical trials are required to confirm the potential advantages of tomosynthesis, initial testing has been encouraging and tomosynthesis images have demonstrated extraordinary anatomic clarity." 

Ongoing studies are underway in an effort to improve upon the existing prototype and to optimize radiographic techniques to produce superb image quality with reduced dose. Researchers also are exploring a new acquisition and viewing workstation based on Siemens' syngo platform with the intent to enhance image processing and workflow. Preliminary clinical trials are planned to begin in the coming months.
The information about this product is preliminary, Siemens says. The product is under development and is not commercially available in the U.S. and its future availability cannot be ensured. The company plans to begin collecting clinical data to share with the FDA.
Also on display was Siemens MAMMOMAT NovationDR full-field digital mammography system designed to meet the demands of modern mammography practices by providing digital screening, diagnosis and stereotactic biopsy capabilities in one system. MAMMOMAT NovationDR features a flat-panel detector based on amorphous sSelenium (aSe) technology and enables a direct conversion of x-ray to digital information. The aSe detector technology has the potential to provide higher spatial resolution and greater clinical detail, resulting in exceptional diagnostic accuracy. At 24 by 29 centimeters, the size of the MAMMOMAT NovationDR image detector allows imaging of a wider range of patient breast sizes, and its new paddle design provides easier and more comfortable patient positioning, the company says. The system also features MammoReportPlus, a multi-modality workstation for mammography with the ability to accept CAD markers from approved vendors. MammoReportPlus provides fast, high-volume mammogram reading, permitting users to switch between eight-view mammographic studies in less than one second - improving workflow in the process. According to Siemens, digital mammography is slated to take off as the older analog installed base ages and the next MQSA requirements hit the streets.