What are we working on?
Awarded and Completed:
Grant Number: 1R42HL106818 - STTR Fast Track
Principal Investigator(s): Ernest V. Garcia, PhD and Kenneth Van Train, MS
Project Period: 02/07/2010 – 02/07/2013
Title: Novel WEB Decision Support System for cardiac image interpretation and reporting
Pre Market Notification 510(k): Accepted on 2/22/2013, K123646
Medical Device now in commercial distribution: Emory Cardiac Toolbox v4 and SmartReport
Today’s cardiac imaging field requires diagnosticians to master an ever-expanding knowledge base (KB) while the time to master this knowledge, apply it to specific tasks and reimbursement are steadily shrinking. These constraints pose a serious healthcare problem that inevitably leads to physician’s errors. Thus new tools are required to assist physicians to timely apply comprehensive, up-to-date objective knowledge and the available patient data to specific clinical problems. The long-term objective of our Fast-Track proposal is to improve the care of cardiac patients and reduce the cost of cardiac image interpretation by developing new tools for a WEB-accessible cardiac toolbox that provides decision support to increase the accuracy of detecting coronary heart disease (CHD). Specifically, we propose a WEB-based system where acquired ECG-gated myocardial perfusion SPECT (MPS) raw images are uploaded to be automatically reconstructed and analyzed to extract regional quantitative parameters of myocardial perfusion and function. These parameters are converted to certainty factors of abnormality and submitted to an imaging decision support system (DSS) that is continuously updated with the latest scientific/clinical knowledge to reach an impression of the patient’s heart status. These conclusions reached by the DSS and justifications for each conclusion are used to automatically generate a web-based structured report for the diagnostician to easily review, learn from the justifications, and either modify and/or approve for optimal accuracy of the diagnosis and prognosis of CHD. Specifically we propose to: 1) develop a novel left ventricular (LV) quantitative algorithm that automatically extracts parameters of left LV regional perfusion and function used to diagnose CHD; 2) develop the LV eXpert (LVX) DSS and 3) design and implement the LV quantification and DSS algorithms using the .net platform so that they can be integrated into our Syntermed infrastructure and deployed over the web and/or used as conventional stand-alone work-stations. In Phase I we will develop a proof-of-principle system where LV perfusion information from MPS studies is analyzed and DSS interpreted for automatic report generation and physician review. In Phase II, the system will be: a) extended to include quantification and DSS of myocardial function, ischemia, viability and clinical risk factors, b) extended to include a methodology to continuously update LVX’s KB, c) automated to link all the reconstruction, processing, quantification, interpretation, and reporting applications, and d) deployed in .net on the web with database and eCommerce accounting capability. Using this process we expect to confirm our primary hypothesis that diagnosticians using our decision support will provide a faster, more accurate diagnosis and prognosis of CHD than those provided by the same diagnosticians without the aid of this system. The system will be commercialized using Syntermed’s successful strategy of other Emory software through: 1) licensing to major instrumentation manufacturers, 2) direct sales to clients that use PC workstations and 3) per WEB-access fee using the existing Syntermed Live network.
Grant Number: 1R43HL123069 – SBIR Phase I
Principal Investigator(s): Jamshid Maddahi, MD and Kenneth Van Train, MS
Project Period: 07/01/2014 – 06/30/2015
Title: Myocardial blood flow quantitation with the novel F-18 Flurpiridaz PET imaging tracer.
Coronary artery disease continues to be a major contributor to the cause of death in the United States. The ability to diagnosis CAD in patients at an early stage has improved over the years resulting in reducing the mortality rate. In nuclear medicine/cardiology, the SPECT and PET myocardial perfusion imaging (MPI) methods and radiopharmaceuticals used clinically over the past 10 years have offered acceptable results for accuracy and diagnosis but have now reached their limit for improvement. This research project will use an exciting new PET MPI tracer called F-18 flurpiridaz which is currently half way through phase III FDA clinical trials. This new PET tracer offers higher spatial and contrast resolution over SPECT MPI and offers higher temporal resolution and longer half life over current PET tracers making it the ideal MPI tracer for the evaluation of patients with suspected CAD. The long-term objective of this SBIR grant is to develop a quantitative method for the relative and absolute quantitation of myocardial perfusion, ventricular function, and myocardial blood flow (MBF), using the new PET MPI tracer, F-18 labeled flurpiridaz. These results will ultimately be incorporated into a commercially available diagnostic tool for clinical use. This SBIR phase I proposal will be used to demonstrate a proof-in-principle of the research and to develop a prototype of the quantitative method for analysis of flurpiridaz PET images. The specific aims for phase I will be 1) to develop and validate a model for absolute quantitation of myocardial blood flow, 2) to develop quantitative normal databases for absolute and relative MBF, 3) to validate and optimize relative quantitation for sizing of defect and defect reversibility, and 4) to evaluate the diagnostic values of relative and absolute F-18 flurpiridaz PET quantitation for detection of CAD. The completion of phase I will produce a prototype quantitative application for the analysis of the flurpiridaz PET MPI. Following the successful completion of phase I, we will submit a phase II proposal to NIH. The research in this phase will include development of new quantitative parameters for the flurpiridaz tracer and an extensive prospective validation of the phase I projects in a much larger database obtained from the phase III FDA flurpiridaz clinical trials. The deliverable at the end of phase II will be a quantitative medical device for the comprehensive analysis of flurpiridaz PET images. The system will be commercialized using Syntermed’s successful strategy through: 1) licensing to major instrumentation manufacturers, 2) direct sales to clients that use PC workstations and 3) per Web-access using the existing Syntermed Live network.