Breast imaging expands beyond traditional boundaries
A variety of new breast imaging technologies debuted and gained new strength at RSNA 2003. The modalities stretched from traditional mammography to digital mammography, breast ultrasound, breast MRI and even a new technology joined radiology's vocabulary -- Somography, which is an ultrasound image configured to look like a mammogram.
GE Medical Systems at RSNA touted its added strength via the recent Instrumentarium acquisition, showcasing the Diamond film-screen system, which can be upgraded using digital stereo, digital spot, and 3-D capability with Instrumentarium's tuned-aperture computed tomography (TACT) technology.
GE also showed a new work-in-progress version of its amorphous silicon-based FFDM system, Senographe DS, featuring a motorized gantry and a smaller tube head. The system uses the same molybdenum/rhodium tube from the Senographe 2000D.
GE also debuted as a works-in-progress a new workstation, the Seno Advantage multimodality breast imaging workstation. Seno Advantage will allow users to view ultrasound, mammography, MR, and PET/CT images. FDA clearance is pending for the system, which GE hopes to make available early next year. It is now being sold in Europe.
Hologic, Inc. at RSNA previewed add-on hardware and software breast tomosynthesis for its first full field digital breast tomosynthesis research system. The works in progress technology brings the promise of a full volume of data produced at the same radiation dose as a conventional screen-film or digital mammogram.
Breast tomosynthesis allows a series of images in slices of 1 mm or less (usually 11 images over a 30 degree range) to be acquired and reconstructed for 3D viewing. Hologic says the technology has the potential to reduce or eliminate overlapping tissue, which can obscure a breast lesion. Tomosynthesis may also provide improved diagnostic information, with reduced breast compression. The technology will be offered as an add-on to Hologic's Lorad Selenia full field digital mammography system.
"We believe that breast tomosynthesis is clearly the wave of the future for digital mammography, and Hologic plans to lead the way in development and commercialization of this tremendously exciting new technology," says Jack Cumming, Hologic chairman and CEO. "Although breast tomosynthesis is still in the early phases of research, we have been very pleased with the rate of progress in our program and the high quality of the initial images we have acquired in our research studies. Over the next several months we plan to extend our research studies to investigate other facets of this technology, the feasibility of reduced breast compression, and utilization of breast tomosynthesis for needle localization and biopsy procedures." Cumming says an FDA filing is expected in 2004.
Eastman Kodak Co. promoted several works-in-progress products for mammography, including computer-aided detection (CAD) software, a mini-PACS and expanded mammography printing capabilities for its DryView 8900 laser imaging system. All three products are set for launch in 2004.
The CAD technology is courtesy of Kodak's September 2003 acquisition of MiraMedica Inc. Kodak received an approvable letter from the FDA for the CAD technology and is about to commence clinical studies with the technology.
Wido Menhardt, general manager for Kodak's CAD business segment, said that mammography is "the jumping off point" for Kodak and eventually the company will expand the CAD product to the other imaging modalities.
A works-in-progress PACS for mammography to manage and store images from a full-field digital mammography system will include diagnostic workstations optimized for reading mammograms. The technology will be designed for a small mammography center or within a full PACS.
Speaking of FFDM, Kodak Health Imaging President Dan Kerpelman says a FFDM system is in the company's future, but it may not be until 2005.
"We are working on digital mammography through the workstations, through archiving, PACS, printing and CAD," he added. "As far as the actual capture solution and whether it will be CR or DR, we have an internal horse race going on about the right thing to do there. Frankly, we are waiting to triangulate with industry readiness, both in clinical terms and economic terms. Reimbursements for mammography are so depressed."
Kodak also is working on a software upgrade to its DryView 8900 laser imaging system to print high-resolution mammography images onto DryView mammography laser imaging film. Images would be available in 8-by-10 inch or 10-by-12 inch sizes.
Kodak also introduced a new mammography screen-film system for enhanced visualization (EV) of abnormalities in breast tissue. Kodak says its MIN-R EV is an upgrade from its MIN-R 2000 screen-film system. The MIN-R EV system is available worldwide.
Sectra Imtec's works in progress Sectra MicroDose Mammography digital system offers a five-fold reduction in radiation compared to traditional film-based systems, the company said. The unit's flat panel detector, made by Stockholm, Sweden-based Mamea Imaging AB, features new photon counting technology that allows higher efficiency (95 percent) and higher patient volumes. The system, which is currently available for sale outside of the U.S., includes the Sectra PACS for processing and archiving digital mammography images.
Sectra's first installation at Helsingborg Hospital Breast Disease Center in Sweden is being used to screen more than 60 women per day, on a normal work schedule. The system also enables totally film-free evaluation on digital display systems.
A total of three systems have been sold to date. The first U.S.-based unit is slated to be installed at the University of North Carolina-Chapel Hill in February or March, according to Hakan Eriksson, marketing manager mammography. Sectra hopes to submit its FDA 510(k) filing in 2004.
Siemens Medical Solutions is currently awaiting the approval of its Pre-Market Approval Application for both the Mammomat NovationDR, a full-field digital mammography system, and the MammoReportPlus soft-copy reading station. The new Mammomat NovationDR is expected to meet the demands of modern mammography practices by providing digital screening, diagnosis, and stereotactic biopsy capabilities -- all in one system, Siemens said.
The MammoReportPlus is currently the only dedicated workstation for mammography, and provides high-volume mammogram reading and optimized workflow. The system's dedicated keypad and roaming/panning function gives easy to full spatial resolution and allows users to switch between eight-view mammographic studies in less than 1 second. MammoReportPlus also is designed to meet future imaging needs and is prepared for digital computer-aided (CAD) applications.
At RSNA Holger Schmidt, president of the Siemens Medical Solutions Special Systems Division, said "the combination of these products will offer a comprehensive solution for modern mammography that optimizes workflow and will make a significant difference in the way.
Fischer Imaging Corp. at RSNA showcased its SenoScan TrueView Digital Mammography system, which the company claims is the first and only mammography system to offer 25-micron native diagnostic resolution. For screening, 50-micron resolution is standard. SenoScan's larger field of view (22x30 imaging areal 11x15 cm in high-resolution mode) accommodates more patients. Its curved breast support allows great patient comfortable and helps reduce motion during exposure. The system's slot-scanning technology and Cesium Iodide CCD receptor also reduce radiation dose. The system utilizes an array of four charged.
Fischer also announced it has received a fast track Small Business Innovation Research grant from the National Cancer Institute (NCI). The $1.2 million grant will fund an effort with IBM to characterize and evaluate the technical performance and clinical efficacy of the advanced IBM T221 flat-panel display as part of Fischer's SenoScan digital mammography review workstation. FDA clearance will be required before the IBM 9-megapixel monitor could be made available to SenoScan customers.
U-Systems, a newcomer from San Jose, Calif., brought a new technology term to the RSNA show floor. Somography is the science of converting ultrasound data into mammographic views. U-Systems' FFBU system automatically images the whole-breast and provides a Somogram of the scanned breast. The Somogram is an ultrasound image configured to look like a mammogram in the standard mammographic views, such as CC and MLO. The Somogram allows one-to-one correlation between the ultrasound images and the mammogram, which is expected to improve and enhance the current ultrasound practice in early detection and diagnosis of breast cancer and breast diseases, U-Systems said.
The FFBU system consists of the Somography Scan Station, Somography Image Processing Computer and Somography View Station. The Somography Scan Station automatically captures ultrasound images of the entire breast in the same manner as a standard mammography system. The scanning procedure can easily be performed by a mammography technologist, with the breast held in the standard mammographic positions under light compression. It uses a high frequency 768-element transducer to acquire 400 to 800 sagittal ultrasound images with one sweep. The entire scan takes less than 60 seconds.
The Somography Image Processing Computer converts 400 to 800 sagittal ultrasound images into six to eight Somograms, which are tomographic ultrasound slices in standard mammographic views. Each Somogram represents a section of the breast tissue approximately 5 to 10 mm thick. Viewing breast tissues in thinner sections is expected to be particularly useful for breasts with dense tissues.
The Somography View Station displays Somograms next to the mammograms. Any area of interest on the mammogram can be easily located on Somograms. Both the original ultrasound sagittal images and constructed orthogonal slices are also displayed to facilitate closer scrutiny if needed. The one-to-one correlation is expected to improve identification of mammographic abnormalities in Somograms and ultrasound sagittal images.
Aurora Imaging Technology, Inc. recently debuted it UltraRODEO imaging technique. RODEO (Rotating Delivery of Excitation Off-resonance) is a proprietary pulse sequence that provides robust fat-suppression, magnetization transfer contrast in an efficient high-resolution acquisition. Fat-suppression is important in reducing the normally high intensity fat signal to maximize contrast with enhancing tumors. Magnetization transfer contrast is used to reduce signal from normal ductal tissue and avoid false positive enhancement from benign lesions. Aurora received FDA 510K clearance of RODEO technique in September. UltraRODEO advances the technique further, providing independent, simultaneous MR imaging of both breasts producing a fat suppressed bilateral exam with unilateral quality.
As a diagnostic tool, the Aurora System can be used in a variety of applications in breast disease management, including: characterizing lesions, detecting occult cancer, determining the extent of cancer, monitoring cancer therapy, evaluating the extent of cancer, monitoring cancer therapy, evaluating patients with positive surgical margins for residual cancer, excluding the existence of cancer in high risk women and evaluating implant integrity and detecting cancer in women with breast augmentation.
Agfa Inc. announced at the show that it is conducting a clinical investigation with Florida Hospital to define the potential of Agfa's Embrace DR Mammography System. The system is designed to change the way mammography images are displayed, archived and retrieved and, ultimately, to better facilitate diagnosis of breast disease in women, Agfa said. Embrace, combined with Agfa's IMPAX enterprise image management system, creates a digital environment that can optimize the mammography workflow and diagnostic process, including examining and managing multimodality breast images.
Agfa also announced the signing of a memorandum of understanding on the distribution of R2's ImageChecker CAD (computer-aided detection) system in Agfa's digital mammography solutions.
Mammography Reporting System Inc. (MRS) at RSNA featured its MRS Mammography Reporting System. The full-featured system includes exam results reporting for all breast-related procedures and a letter generation system.
The company also offers the MRS QA Plus for facilities desiring to continue dictating in the traditional manner. This system has the same user interface and database design as the MRS Mammography Reporting Systems and generates lay-language patient result letters, tracks problem cases, generates problem case follow-up letters and recall letters. It also generates a variety of statistical reports, including medical audits.
For low-volume facilities, MRS offers the MRS Basic. It aids data collection, produces basic patient result letters, recall letters and statistical reports. An upgrade path exists to the two higher performance system, allowing a facility to smoothly transition data.
All of MRS' systems incorporate the Breast Imaging Reporting and Data System (BI-RADS) of the American College of Radiology, Copyright 2001. Relevant data can be exported for participation in the ACR National Mammography Database.
GE Medical Systems at RSNA touted its added strength via the recent Instrumentarium acquisition, showcasing the Diamond film-screen system, which can be upgraded using digital stereo, digital spot, and 3-D capability with Instrumentarium's tuned-aperture computed tomography (TACT) technology.
GE also showed a new work-in-progress version of its amorphous silicon-based FFDM system, Senographe DS, featuring a motorized gantry and a smaller tube head. The system uses the same molybdenum/rhodium tube from the Senographe 2000D.
GE also debuted as a works-in-progress a new workstation, the Seno Advantage multimodality breast imaging workstation. Seno Advantage will allow users to view ultrasound, mammography, MR, and PET/CT images. FDA clearance is pending for the system, which GE hopes to make available early next year. It is now being sold in Europe.
Hologic, Inc. at RSNA previewed add-on hardware and software breast tomosynthesis for its first full field digital breast tomosynthesis research system. The works in progress technology brings the promise of a full volume of data produced at the same radiation dose as a conventional screen-film or digital mammogram.
Breast tomosynthesis allows a series of images in slices of 1 mm or less (usually 11 images over a 30 degree range) to be acquired and reconstructed for 3D viewing. Hologic says the technology has the potential to reduce or eliminate overlapping tissue, which can obscure a breast lesion. Tomosynthesis may also provide improved diagnostic information, with reduced breast compression. The technology will be offered as an add-on to Hologic's Lorad Selenia full field digital mammography system.
"We believe that breast tomosynthesis is clearly the wave of the future for digital mammography, and Hologic plans to lead the way in development and commercialization of this tremendously exciting new technology," says Jack Cumming, Hologic chairman and CEO. "Although breast tomosynthesis is still in the early phases of research, we have been very pleased with the rate of progress in our program and the high quality of the initial images we have acquired in our research studies. Over the next several months we plan to extend our research studies to investigate other facets of this technology, the feasibility of reduced breast compression, and utilization of breast tomosynthesis for needle localization and biopsy procedures." Cumming says an FDA filing is expected in 2004.
Eastman Kodak Co. promoted several works-in-progress products for mammography, including computer-aided detection (CAD) software, a mini-PACS and expanded mammography printing capabilities for its DryView 8900 laser imaging system. All three products are set for launch in 2004.
The CAD technology is courtesy of Kodak's September 2003 acquisition of MiraMedica Inc. Kodak received an approvable letter from the FDA for the CAD technology and is about to commence clinical studies with the technology.
Wido Menhardt, general manager for Kodak's CAD business segment, said that mammography is "the jumping off point" for Kodak and eventually the company will expand the CAD product to the other imaging modalities.
A works-in-progress PACS for mammography to manage and store images from a full-field digital mammography system will include diagnostic workstations optimized for reading mammograms. The technology will be designed for a small mammography center or within a full PACS.
Speaking of FFDM, Kodak Health Imaging President Dan Kerpelman says a FFDM system is in the company's future, but it may not be until 2005.
"We are working on digital mammography through the workstations, through archiving, PACS, printing and CAD," he added. "As far as the actual capture solution and whether it will be CR or DR, we have an internal horse race going on about the right thing to do there. Frankly, we are waiting to triangulate with industry readiness, both in clinical terms and economic terms. Reimbursements for mammography are so depressed."
Kodak also is working on a software upgrade to its DryView 8900 laser imaging system to print high-resolution mammography images onto DryView mammography laser imaging film. Images would be available in 8-by-10 inch or 10-by-12 inch sizes.
Kodak also introduced a new mammography screen-film system for enhanced visualization (EV) of abnormalities in breast tissue. Kodak says its MIN-R EV is an upgrade from its MIN-R 2000 screen-film system. The MIN-R EV system is available worldwide.
Sectra Imtec's works in progress Sectra MicroDose Mammography digital system offers a five-fold reduction in radiation compared to traditional film-based systems, the company said. The unit's flat panel detector, made by Stockholm, Sweden-based Mamea Imaging AB, features new photon counting technology that allows higher efficiency (95 percent) and higher patient volumes. The system, which is currently available for sale outside of the U.S., includes the Sectra PACS for processing and archiving digital mammography images.
Sectra's first installation at Helsingborg Hospital Breast Disease Center in Sweden is being used to screen more than 60 women per day, on a normal work schedule. The system also enables totally film-free evaluation on digital display systems.
A total of three systems have been sold to date. The first U.S.-based unit is slated to be installed at the University of North Carolina-Chapel Hill in February or March, according to Hakan Eriksson, marketing manager mammography. Sectra hopes to submit its FDA 510(k) filing in 2004.
Siemens Medical Solutions is currently awaiting the approval of its Pre-Market Approval Application for both the Mammomat NovationDR, a full-field digital mammography system, and the MammoReportPlus soft-copy reading station. The new Mammomat NovationDR is expected to meet the demands of modern mammography practices by providing digital screening, diagnosis, and stereotactic biopsy capabilities -- all in one system, Siemens said.
The MammoReportPlus is currently the only dedicated workstation for mammography, and provides high-volume mammogram reading and optimized workflow. The system's dedicated keypad and roaming/panning function gives easy to full spatial resolution and allows users to switch between eight-view mammographic studies in less than 1 second. MammoReportPlus also is designed to meet future imaging needs and is prepared for digital computer-aided (CAD) applications.
At RSNA Holger Schmidt, president of the Siemens Medical Solutions Special Systems Division, said "the combination of these products will offer a comprehensive solution for modern mammography that optimizes workflow and will make a significant difference in the way.
Fischer Imaging Corp. at RSNA showcased its SenoScan TrueView Digital Mammography system, which the company claims is the first and only mammography system to offer 25-micron native diagnostic resolution. For screening, 50-micron resolution is standard. SenoScan's larger field of view (22x30 imaging areal 11x15 cm in high-resolution mode) accommodates more patients. Its curved breast support allows great patient comfortable and helps reduce motion during exposure. The system's slot-scanning technology and Cesium Iodide CCD receptor also reduce radiation dose. The system utilizes an array of four charged.
Fischer also announced it has received a fast track Small Business Innovation Research grant from the National Cancer Institute (NCI). The $1.2 million grant will fund an effort with IBM to characterize and evaluate the technical performance and clinical efficacy of the advanced IBM T221 flat-panel display as part of Fischer's SenoScan digital mammography review workstation. FDA clearance will be required before the IBM 9-megapixel monitor could be made available to SenoScan customers.
U-Systems, a newcomer from San Jose, Calif., brought a new technology term to the RSNA show floor. Somography is the science of converting ultrasound data into mammographic views. U-Systems' FFBU system automatically images the whole-breast and provides a Somogram of the scanned breast. The Somogram is an ultrasound image configured to look like a mammogram in the standard mammographic views, such as CC and MLO. The Somogram allows one-to-one correlation between the ultrasound images and the mammogram, which is expected to improve and enhance the current ultrasound practice in early detection and diagnosis of breast cancer and breast diseases, U-Systems said.
The FFBU system consists of the Somography Scan Station, Somography Image Processing Computer and Somography View Station. The Somography Scan Station automatically captures ultrasound images of the entire breast in the same manner as a standard mammography system. The scanning procedure can easily be performed by a mammography technologist, with the breast held in the standard mammographic positions under light compression. It uses a high frequency 768-element transducer to acquire 400 to 800 sagittal ultrasound images with one sweep. The entire scan takes less than 60 seconds.
The Somography Image Processing Computer converts 400 to 800 sagittal ultrasound images into six to eight Somograms, which are tomographic ultrasound slices in standard mammographic views. Each Somogram represents a section of the breast tissue approximately 5 to 10 mm thick. Viewing breast tissues in thinner sections is expected to be particularly useful for breasts with dense tissues.
The Somography View Station displays Somograms next to the mammograms. Any area of interest on the mammogram can be easily located on Somograms. Both the original ultrasound sagittal images and constructed orthogonal slices are also displayed to facilitate closer scrutiny if needed. The one-to-one correlation is expected to improve identification of mammographic abnormalities in Somograms and ultrasound sagittal images.
Aurora Imaging Technology, Inc. recently debuted it UltraRODEO imaging technique. RODEO (Rotating Delivery of Excitation Off-resonance) is a proprietary pulse sequence that provides robust fat-suppression, magnetization transfer contrast in an efficient high-resolution acquisition. Fat-suppression is important in reducing the normally high intensity fat signal to maximize contrast with enhancing tumors. Magnetization transfer contrast is used to reduce signal from normal ductal tissue and avoid false positive enhancement from benign lesions. Aurora received FDA 510K clearance of RODEO technique in September. UltraRODEO advances the technique further, providing independent, simultaneous MR imaging of both breasts producing a fat suppressed bilateral exam with unilateral quality.
As a diagnostic tool, the Aurora System can be used in a variety of applications in breast disease management, including: characterizing lesions, detecting occult cancer, determining the extent of cancer, monitoring cancer therapy, evaluating the extent of cancer, monitoring cancer therapy, evaluating patients with positive surgical margins for residual cancer, excluding the existence of cancer in high risk women and evaluating implant integrity and detecting cancer in women with breast augmentation.
Agfa Inc. announced at the show that it is conducting a clinical investigation with Florida Hospital to define the potential of Agfa's Embrace DR Mammography System. The system is designed to change the way mammography images are displayed, archived and retrieved and, ultimately, to better facilitate diagnosis of breast disease in women, Agfa said. Embrace, combined with Agfa's IMPAX enterprise image management system, creates a digital environment that can optimize the mammography workflow and diagnostic process, including examining and managing multimodality breast images.
Agfa also announced the signing of a memorandum of understanding on the distribution of R2's ImageChecker CAD (computer-aided detection) system in Agfa's digital mammography solutions.
Mammography Reporting System Inc. (MRS) at RSNA featured its MRS Mammography Reporting System. The full-featured system includes exam results reporting for all breast-related procedures and a letter generation system.
The company also offers the MRS QA Plus for facilities desiring to continue dictating in the traditional manner. This system has the same user interface and database design as the MRS Mammography Reporting Systems and generates lay-language patient result letters, tracks problem cases, generates problem case follow-up letters and recall letters. It also generates a variety of statistical reports, including medical audits.
For low-volume facilities, MRS offers the MRS Basic. It aids data collection, produces basic patient result letters, recall letters and statistical reports. An upgrade path exists to the two higher performance system, allowing a facility to smoothly transition data.
All of MRS' systems incorporate the Breast Imaging Reporting and Data System (BI-RADS) of the American College of Radiology, Copyright 2001. Relevant data can be exported for participation in the ACR National Mammography Database.