CT Screening Eligibility Criteria Sample Clauses

CT Screening Eligibility Criteria. Acquisition of CT scans will be standardized across clinical sites by training sites and using an imaging procedures core manual. The protocol will include volume acquisition thin section obtained at suspended breath hold at full inspiration (TLC) and full expiration (RV). Images will be reconstructed using a smooth or standard filter; the protocol is detailed in Appendix 6. The radiology technologists at the clinical sites will be trained to the HRCT data collection protocol. The clinical site will evaluate HRCT images to determine screening eligibility of the study candidate. The grading system used by the clinical sites to evaluate HRCT scans will be standardized and site personnel will be trained to use it. The HRCT eligibility criteria will be assessed by determining parenchymal destruction and emphysema heterogeneity scores using the total lung capacity (TLC) scan and the definitions below (Sections 8.5.1.1 and 8.5.1.2). The site will use FDA cleared software, which may include VCAR (GE Medical Systems, Milwaukee, WI), Apollo (VIDA, Coralville, IA), syngo Lung Care CT (Siemens Healthcare Solutions, Deerfield, IL), XxXxx Visia CT Lung System (XxXxx Medical Solutions, Milwaukee, WI), Xxxxxx (Intrasense, Montpellier, France), or other 510k cleared software to measure lung density to determine parenchymal destruction. The site reader will use the parenchymal destruction scores provided by the software to calculate emphysema heterogeneity using a provided worksheet. The CT study must exhibit sufficient landmarking to be evaluated using the software as it is intended for delineating lobar parenchymal destruction.
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Related to CT Screening Eligibility Criteria

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