With the considerable success of our phase 2 SBIR, we have achieved the completion of lung image analysis software that segments and thoroughly measures the lungs and their five lobes along with the airway tree. We have recently just achieved 510(k) FDA clearance for Pulmonary Workstation (PW 2.0) which now opens the door to the use of the Phase 2 software in the clinical arena. Our first phase II grant period, for which we seek and extension, was targeting the use of this software in the context of a clinical setting, guiding decisions and interventions associated with the placement of endobronchial valves and guiding other endobronchial interventions such as is associated with lung cancer assessment. While enthusiasm for PW2.0 remains high in interventional circles, it has also been adopted by numerous large multi-center NIH sponsored research projects as well as commercial and device company clinical trials in the US and abroad. In order to improve the workflow and to minimize human interactions, as well as to accommodate improved measures related to low lung volume scans being gathered to assess air trapping in both COPD and Asthma trials, we have established a new series of specific aims, and these new goals are directly in line with PA-08-056 seeking Phase II SBIR renewal which are associated with the building of complex instrumentation and clinical research tools to establish new biomarkers to differentiate phenotypes in a disease entity now lumped together as a single pathology. The goal of this application is to focus specifically on COPD and Asthma to complement our original emphysema focus. 1. Registration for longitudinal analysis and air trapping: we will integrate a method for accurate (1 mm or better) matching of lung volumes across time and change of lung volumes. 2. Speed up analysis for high throughput sites: The original software was designed to handle a typical clinical load in a pulmonary bronchoscopy suite that would typically be at most 3-4 cases per day. With the software being used to analyze up to 20,000 lung volume scans over a three year period in just one project, we have devised a plan to introduce batch processing steps and further develop our segmentation approaches to minimize human interventions. 3. Measurements of airway at bifurcations: Because many disease processes begin with irritant deposition and inflammation at the airway bifurcations, VIDA proposes to measure the whole airway tree using the optimal surface finding techniques developed for the segments in phases I and II. 4. Improved segmentation and automatic naming of six key airway paths: COPDGene and others have developed a phenotyping strategy for identifying and characterizing airway disease using the scion of six specific segmental airways. VIDA herein proposes methods for reliable automatic segmentation, naming and measurement of these smaller airways. All the newly developed tools resulting from the four aims above will be integrated into Pulmonary Workstation. Throughout the project we will continuously make updated versions of Pulmonary Workstation available to the NIH sponsored COPDGene and SPIROMICS image coordination and analysis centers for evaluation including time trials throughout years one and two. During this period user feedback will be used to further optimize the tools. A full rollout and testing of the system is planned for year three
The project defined herein is to extend VIDA Diagnostics'successful Phase II SBIR, (Tissue and Airway Assessment for Emphysema Interventions) which resulted in an FDA approved lung densitometry and airway measurement software application. Our goals are to further develop the airway and parenchymal measurements to provide more ways to phenotype subjects and more repeatable endpoints for clinical trials.