CAD: Expanding Applications and Accuracy

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While researchers outlined the clinical might and cost-effectiveness of mammography CAD in presentations at this year's RSNA, a growing number of vendors showed off the latest and greatest CAD technology. CAD has come far in just a few short years-progressing from its roots in analog mammography to digital mammography and MRI and now including CAD for x-ray and CT chest images and CT colonography. These days, 25 to 30 percent of all screening mammograms are interpreted with the help of CAD, and new research indicates that the addition of CAD to screening mammography is cost-effective. So it's no surprise that several new vendors threw their hats into the CAD ring and launched mammography CAD products at the show-with a few more poised to hit the streets in the next year. And established companies continue to carve out their space with stratified solutions targeted for various segments of the market from low volume to high volume sites.

MRI CAD systems demonstrated their productivity and clinical value, and ultrasound bounced into the CAD realm with the first CAD system for breast ultrasound expected to hit the US market in 2005.

Healthcare facilities thinking about CAD for lung lesions have two choices - x-ray based CAD and CT chest CAD, with makers of CT-based systems pointing to workflow enhancements made possible with CAD-aided navigation of the volumes of CT data. And CT colon CAD, a relative of lung CT CAD technology, is available to help radiologists sort through the volumes of data created by CT colonographies and highlight areas for further review.

(Note: companies appear in alphabetical order.)



3TP Imaging Sciences showed its 3TP breast imaging enhancement software for MRI workflow and launched its Total Solution for Prostate MR Imaging.

3TP breast imaging software automatically applies a CAD algorithm to breast MRI studies, creates DICOM 3 images and sends the images to PACS and viewing stations. Clinical studies indicate 96 percent sensitivity and 82 percent specificity for solid lesions, the company said. Additional capabilities include MIPS, motion correction, subtraction and 3D volume. The system is compatible with MRIs of 1.0T or greater and any DICOM 3 MRI system or workstation.

Total Solution for Prostate Imaging is a computer analysis program for prostate staging. It incorporates a scientifically validated contrast enhancement method and correlates images to pathology results, 3TP said. The technology is DICOM 3 compatible and integrates color images with PACS.



Agfa Corp. announced plans to integrate and distribute Medicsight's Computer Assisted Reading (CAR) software in its solutions for radiology and other clinical specialties.

The two companies signed a letter of intent that outlines plans to integrate Medicsight's Colon CAR, Lung CAR and Heart Screen software into Agfa's solutions for radiology and clinical specialties on the global market. Moreover, Agfa will be granted limited exclusivity to distribute the integrated solutions. The research departments of Agfa and Medicsight will work closely together to develop completely integrated solutions, assisting radiologists in detecting and accurately measuring colon polyps, lung lesions and coronary artery calcifications.

During RSNA, Agfa demonstrated both Lung CAR and Colon CAR software (which both recently gained FDA marketing clearance) at its booth.



CADimas shared its works in progress breast MRI CAD system, CADimas. The CADimas breast MRI CAD system discriminates benign from malignant lesions using a variety of computer and interpreted features, including kinetics, intensity, morphology and texture, CADimas said. FDA approval is anticipated in 2006. The system incorporates a computer-intensity feature, which has been found to be particularly useful for identifying cancers, such as DCIS (ductal carcinoma in situ), that could be missed using other breast MRI CAD systems. The company plans on making this feature available as an add-on module to existing breast MRI CAD systems within the next year.



Cedara Software unveiled B-CAD breast ultrasound CAD, which the company describes as an image analysis scheme to determine more than 20 sonographic lesion characteristics and an advanced decision engine to help identify benign and malignant lesions. B-CAD can provide the radiologist with CAD information on the clinically relevant characteristics and features of the target of interest as well as the probability that a target lesion is either benign or malignant, the company said. B-CAD can be seamlessly integrated with PACS and mammography workflows and used in conjunction with live ultrasound through video acquisition solutions. It can be deployed in Cedara's Multi-Modality CAD Workstation for Breast Imaging to provide access to all forms of breast image data and CAD technology. The FDA approval for B-CAD is in process, with a product launch anticipated by mid-2005, according to Cedara.



Confirma Inc. highlighted the next generation of its CADstream MRI processing technology which allows radiologists to access, view and reference patients' mammography and ultrasound studies at the same time they are viewing the results of breast MRIs. The updated version also gives breast surgeons access to more detailed data from breast MRI exams on patients' tumor size, classification and location. The core CADstream system provides an automated way to process and interpret breast MRI studies and features advanced CAD analysis and standardized processing and interpretation. Core features include image registration, MPR, subtraction images, angiogenesis maps, interactive real-time curves, MIPs and volume summaries. Advanced automated features include a treatment planning portfolio, morphology analysis, advanced interactive MIPs, advanced DICOM and interventional guidance. The company also announced that a multimodality ready feature is under clinical development.



Eastman Kodak Co. entered the CAD market with the announcement of the recent FDA approval of its mammography CAD system. Shipments are beginning immediately, the company said.

The system consists of a digitizer for input of traditional film mammograms, a computer and CAD software, and a report station with a PC and monitor. Engineered for ease of use and smooth integration into existing workflow, the system offers an intuitive user interface and small footprint. It will be sold as a unit, although facilities may purchase additional report stations.

Clinical trial results submitted to the FDA document that 39.4 percent of missed breast cancers could have been detected 14.8 months earlier using Kodak CAD technology, according to the company. Approximately 95 percent of patient mammography images in the U.S are captured on x-ray film, Kodak said.



EDDA Technology was a new vendor on the RSNA floor debuting its IQQA-Chest v1.0 soft-copy chest CAD product that seeks to help in the detection and quantification of small (5-15 mm) lung nodules and lesions in digital radiographic chest images. EDDA calls it Intelligent/Interactive Qualitative and Quantitative Analysis.

IQQA-Chest supports physicians in the visualization, identification, evaluation and reporting of pulmonary lesions and nodules. Geared toward optimizing workflow, the system features a three-task approach, with an Image Reading page, Region of Interest (ROI) Analysis page and Clinical Report page. The Image Reading page features a DICOM-compliant patient study selection, image visualization toolkits with multiple nodule-specific viewing modes and mechanisms for physicians to mark and select lesions. ROI Analysis page features include the display of patient and imaging related information from DICOM, lesion/nodule segmentation in automatic and manual mode, instantaneous automatic computation of quantitative measurements from segmentation results (length, width, average size, area, circularity, mean intensity, density) and means for physicians to input the diagnosis (likelihood of malignancy). And the Clinical Report page provides automatic generation of a clinical report that includes measurements upon physician-confirmed diagnosis, the physician with a way to input notes and digital signature and secures the report with a time stamp and a report ready for printing or storage in DICOM Structured Report format.

The IQQA-Chest software "helps reduce inter-observer variation and to improve the detection rate of actionable nodules, especially small nodules (5-15mm)," according to a study presented in October at the 11th International Conference on Screening for Lung Cancer in Rome.

IQQA-Chest is available for sale in the U.S. as well as the E.U. and China. EDDA is embarking on a sales strategy of direct and OEM generated sales. Two units have been installed in China.



Fischer Imaging Corp. and iCAD, Inc. penned an expanded development and distribution agreement that include iCAD's iAD product.

The recently approved iAD allows women to access CAD screenings of their mammograms at breast imaging centers where both traditional film and digital technologies are used. Fischer and iCAD have a previous agreement that covers iDM CAD integrated with the Fischer SenoScan digital mammography system. The new agreement enables Fischer to offer its customers a complete
CAD solution for both digital and traditional analog applications.



GE Healthcare announced the integration of a custom version of Confirma's CADstream breast MRI CAD system and FDA clearance for its next-generation Advanced Lung Analysis technology.

The new breast MRI CAD technology, called the GE CADstream system, is based on Confirma's CADstream MRI CAD system. GE CADstream will be integrated with the GE Advantage Workstation (AW) and the new EXCITE HD package VIBRANT to provide a complete breast MRI solution. GE CADstream will allow CADstream users to read their CAD-processed breast MRI studies on the GE AW. CADstream enables the automatic post-processing of breast MRI studies and provides essential acquisition, processing and interpretation capabilities. Under an agreement between GE and Confirma announced earlier this year, GE will market and distribute the GE CADstream system to its MRI customers worldwide. Together, the technologies provide high-quality image analysis and a standardized process for image interpretation to facilitate a more thorough, non-invasive exam for diagnosing breast cancer, GE said.

CADstream enhances the efficiency and workflow of breast MRI studies by automating data analysis, improving image management and correcting for patient movement, which assists radiologists in the interpretation, standardization and reporting of these data-intensive studies. CADstream's core automated features include adaptive, high-order image registration (2D/3D), multi-planar reformatting, subtractions, angiogenesis maps, interactive real-time contrast curves, maximum intensity projections (MIPs) and volume summaries.

GE's Signa EXCITE HD system increases the speed and power of MRI by enabling massively simultaneous imaging in multiple channels. VIBRANT, high-resolution software for breast assessment, enables a non-invasive imaging procedure that uses magnets and radio waves to visualize both breasts.

The companies also highlighted the expansion of clinical indications for breast MRI exams underscored by a 40 percent per year increase in the number of breast MRI examinations in the United States since 1999 and updated guidelines from the American Cancer Society indicating that breast MRI, when used with mammography, may enhance the effectiveness of screening and diagnosis. Additionally, research published in the New England Journal of Medicine suggests that breast MRI studies can be effective in finding tumors in women at high risk for breast cancer. Approximately 8.5 million women are at high risk for breast cancer in the United States.

GE Healthcare's next-generation Advanced Lung Analysis technology is designed to help radiologists evaluate and assess nodules and other lesions in the lung. The FDA clearance included a new feature within Advantage ALA called digital contrast agent (DCA) that automatically highlights suspicious anatomical regions, such as lung nodules, to assist and complement the physician during the reading process. The Advanced Lung Analysis application provides clinicians with a tool to track and measure the volume of lung nodules. The technology features 3D volume measurement, enabling clinicians to better see changes in tissue volume to improve both patient diagnosis and patient care. Other features include low dose automated pulmonary nodule analysis, three-dimensional segmentation of nodule volume with vessel removal, automated analysis of initial and follow-up scans for volume growth, bookmark areas of interest for follow-up analysis, dual exam review and a patient report that quantifies growth rate and doubling time for lesions.



Hologic, Inc. highlighted at RSNA an agreement with iCAD to market its CAD systems.

The two companies signed a private label agreement to produce and market film-based computer aided detection (CAD) systems. Under the agreement, iCAD will manufacture film-based CAD systems for Hologic targeted to serve lower case-volume mammography clinics. The companies estimate that these clinics comprise over half the potential market for breast cancer analog CAD products.  



iCAD, Inc. launched the SecondLook 500M with integrated CADstream technology, highlighted distribution agreements with Siemens Medical Solutions, Hologic Inc. and Vital Images and showed off new characterization tools on its SecondLook viewer and SecondLook 300M, a work-in-progress.

iCAD and Confirma announced a strategic alliance to integrate mammography and MRI CAD technologies to create a multimodality CAD solution. Under the terms of the agreement, SecondLook 500M incorporates the early breast cancer detection capabilities of the iCAD Second Look family of film-based mammography systems and breast MRI CAD capabilities of CADstream. Results of the CADstream analysis are available on the SecondLook review station, allowing radiologists concurrent access to mammography and MRI studies and the CADstream system for CAD results while reviewing original patient films. CADstream technology enhances efficiency and workflow by facilitating management, correcting for patient movement and providing data registration and multiplanar summaries.

iCAD and Siemens also signed a new agreement under which Siemens will integrate and distribute iCAD's Second Look Digital CAD software for use with Siemens MAMMOMAT NovationDR digital mammography system cleared for sale globally, but not yet available for sale in the U.S. Subject to FDA approval, the iCAD product release is expected in 2005.

iCAD, Inc. and Hologic Inc. also  announced a private label agreement to produce and market film-based CAD systems. Under the agreement, iCAD will manufacture systems for Hologic to serve lower case-volume mammography clinics, which the companies estimate comprise over half of the potential market for breast cancer analog CAD products.

iCAD and Vital Images, Inc. signed a non-exclusive agreement to integrate iCAD's SecondLook CT Colon CAD application into Vitrea 2, Vital Images' flagship software. The new CAD capability is intended to assist physicians in finding polyps that could lead to colon cancer. Under this agreement, Vital Images will distribute the new CAD option pending FDA regulatory review.

New on iCAD's SecondLook Viewer is the SureLook characterization tool that enables high-resolution zoom on marked spots. The feature provides information about why the spot was marked: number of calcifications and intensity information. The same functionality is available for unmarked areas.
 
iCAD also showed SecondLook 300 as a work-in-progress. The system features a touch-screen monitor with barcode reading and DICOM images and report worklists. SecondLook 300 will be available in the first quarter of 2005.



Median Technologies showcased CAD-Lung, a work-in-progress chest CT CAD solution at the Sectra booth.

CAD-Lung is based on Median CAD-Platform, a 3D image analysis platform, and is optimized for chest CT analysis. The software runs within a web browser and provides automatic region of interest detection, automatic 3D nodule segmentation and automatic characterization. CAD-Lung facilitates nodule follow-up including tracking of the evolution of nodules and detection of new nodules. With CAD-Lung, the radiologist can automatically pair nodules between two datasets of the same patient. It includes 2D and 3D visualization tools, including MIP, MPR, zoom, cine, slab and pan and report generation tools.



Medicsight Inc. highlighted recently signed letters of intent with Agfa and Viatronix and a commercial agreement with Vital Images for distribution of its medical imaging software.

The agreements cover Medicsight Colon CAR, an image analysis software tool for use with CT colonography to aid the search for and measurement of potential colorectal polyps, Medicsight Lung CAR, which assists in evaluation of lesions or nodules found during lung CT scans and Medicsight Heart Screen, which assists in identification and quantification of coronary artery calcification.



Neurognostics, Inc. at RSNA displayed an fMRI CAD system under development as part of its MindState product suite.

The new system could be used to help interpret fMRI scans by providing a paradigm for use, protocols and comparative norms through a database. The company plans to have a data-acquisition device and platform complete by RSNA 2005. At that point, Neurognostics will begin acquiring the data to build the database with FDA approval and a product launch to follow, the company said.



R2 Technology Inc. used RSNA as the launching pad for ImageChecker DMax CAD system and DigitalNow software, and demonstrated its PeerView feature on motorized viewers. The company also highlighted ImageChecker CT for detection of lung lesions on CT studies.

Designed for high-volume use, the new ImageChecker DMax CAD system is powered by a new high-volume, high-performance laser scanner engineered by Array Corp. for R2. Array's digitizer offers 50-micron resolution and is noise-reducing system capable; the scanner can scan a mammography film every 30 seconds. R2 also announced an exclusive agreement with Array for this new laser film scanner, engineered specifically for the ImageChecker DMax system.

The company also showcased DigitalNow software, an archiving enabler to help prepare for the transition to digital mammography. DigitalNow features universal compatibility with all DICOM workstations and flexible electronic patient data system integration.

PeerView software, which provides an immediate display of a high-resolution image of CAD-identified regions, is newly available on motorized viewers.

R2 also highlighted the July approval of ImageChecker CT for detection of nodules during review of chest CT studies. The CAD algorithms examine the CT study in three dimensions and automatically detect areas of interest to increase accuracy by reducing observational oversights. ImageChecker CT also features workflow enhancing tools, automatic measurement of current and previous nodules and characterization information of detected nodules. The streamlined nodule review process eliminates the need for the radiologist to manually select and segment nodules for measurement and produces consistent reproducible measurements. The process automatically loads and co-registers images of the same nodule taken at different periods of time and calculates the change in size for substantial productivity improvements. The review process has been incorporated into R2's stand-alone workstation and workstations from Sectra and Kodak, which also showed the new feature during RSNA.
   
R2 also showed ImageChecker LS, a work in progress, for lower volume facilities.



Riverain Medical introduced the RapidScreen CAD system for chest x-ray early lung cancer detection.

RapidScreen is designed to aid detection by highlighting suspicious areas on chest x-rays. The CAD system helps radiologists rapidly locate areas that warrant further review. Clinical trials demonstrated a 23 percent increase in detection for lung nodules ranging from 9 to 14 millimeters, the company said. Currently, only 15 percent of cancers are detected when they are small pulmonary nodules in the 9 to 14 mm size, which represents an opportunity for earlier treatment when lung cancer may be cured or controlled in up to 85 percent of all cases. RapidScreen is based on pattern-recognition technology featuring fuzzy logic and neural networks.



Siemens Medical Solutions debuted syngo Colonography with PEV (polyp enhanced viewing), a companion to NEV (nodule enhanced viewing) for chest CT studies.

Among the advanced applications for CT that Siemens introduced at RSNA were syngo Colonography with PEV software, the first FDA 510(k) cleared and commercially available enhanced colon viewing technology, the company said. Polyp Enhanced Viewing (PEV), an optional add-on to the syngo Colonography application, is designed as a second-reader tool for automated identification of lesions in the colon. PEV can be activated as the radiologist begins the primary read, with the results ready for reviewing as the radiologist confirms the end of the primary read. The PEV tool then highlights potential lesions that were not marked by the radiologist, in addition to all potential lesions marked by the radiologist during the first read, and also indicates potential lesions marked by the radiologist that were not visualized by the PEV tool. Further workflow enhancements to syngo Colonography include automated polyp measurement and visualization of unseen areas.

Siemens also offers syngo LungCARE, a lung viewing technology that consists of a series of tools and programs to support the visualization, evaluation and follow-up of pulmonary nodules and lesions. The technology offers 3D visualization of thin slices and lets physicians rotate images for close-up inspection, complete automatic calculations of volume and diameter and obtain instantaneous 3D segmentations. The NEV feature serves as a second-reader tool that can be used to highlight potential abnormalities.

The company also highlighted its purchase of CADVision in the summer of 2004 and showed a prototype analog and digital mammography CAD system that may be introduced by fall 2005. Siemens shared second-tier classification software designed to improve the specificity of CAD by quantifying spiculation. The classification tool is not yet available but under active validation.



VuCOMP showcased its M-Vu mammography CAD system at RSNA.

M-Vu uses proprietary image-understanding algorithms to highlight mammographic abnormalities. M-Vu is designed to provide a low false-positive rate while detecting the subtle abnormalities in mammograms, such as small masses and architectural distortions and calcifications. M-Vu relies on a fundamentally different algorithmic approach than typical learn-by-example technologies, the company said. The first M-Vu system, which may hit the market in late 2005 pending FDA approval, will be designed for film-based mammography; a software upgrade for digital mammography will be available at a later date.