BDI, Inc. — Department of Health and Human Services STTR Phase I: NIAMS

Description

PROJECT SUMMARY ABSTRACT As people age they steadily lose bone mass and their bones become fragile and increasingly prone to hip and other fractures and this can prove fatal The American College of Radiology therefore recommends that assessment of bone mineral density BMD be performed in post menopausal women and all people over the age of every two years If indicated preventive measures and medications can effectively decrease risk of fractures BMD is usually measured by DXA dual energy x ray absorptiometry But very often BMD is not assessed when indicated for a variety of reasons patients do not know they need BMD assessment health care providers have no systematic way to identify and notify patients who need BMD assessment and BMD assessment usually requires a separate referral and reimbursement We have a solution that could help to address this need while presenting an opportunity for both radiologists and our own company BDI INC to profit by sharing reimbursement We created patented and published a software solution that uses an algorithm to accurately measure BMD from previously acquired CT scans Hence if a patient is either scheduled to undergo a chest CT scan or has had a CT scan in the last years we can measure BMD and obviate the time trouble radiation exposure and expense of a DXA scan which would be a separate procedure We plan to offer BMD measurement as an add on service and share the CMS reimbursement of $ with referring radiologists Our primary target market will be individuals undergoing low radiation lung CT scans LCS to assess risk of lung cancer New expert guidelines mandate annual scans for current or former smokers hence the volume of CT scans will increase by an estimated million per year However our current algorithm was created using high resolution cardiac CT scans To similarly measure BMD from LCS used for lung cancer screening we propose to obtain DXA scans and chest CT scans using parameters that are commonly used with low dose lung imaging develop algorithms appropriate to these acquisition protocols Aim validate against DXA as we did previously with higher resolution cardiac CT scans Aim and determine retest reproducibility to ensure that our method can be used for serial assessment of BMD Aim both as a screening strategy and to evaluate the effectiveness of medications that inhibit bone loss Recruitment and scanning will be performed by our LA BioMed subcontractor Site PI Dr Matthew Budoff who currently operate CT scanners and a DXA scanner and image to low radiation CT scans per day partly for research protocols Our feasibility criteria are create an algorithm for LCS identify the thoracic vertebrae that produce the best concordance with DXA and achieve retest reproducibility of or less A follow on Phase II application will propose to validate both algorithms in a large multi ethnic cohort the MESA Study to ensure that our algorithms can accurately and reproducibly assess BMD from either high resolution or low resolution serial chest CT scans in all ethnic groups and in a wide range of body sizes PROJECT NARRATIVE BDI INC proposes to develop and validate an algorithm based method to serially measure bone mineral density BMD from previously acquired high resolution or low resolution chest CT scans to screen for the presence of osteoporosis that would be associated with increased risk of hip and other types of fractures in post menopausal women and all individuals over the age of There are currently more than million chest CT scans performed annually we particularly wish to target the million additional CT scans that estimates indicate will be performed annually because of recent recommendations to perform annual low resolution CT scans in current or former smokers to screen for the presence of lung cancer because the vast majority of these individuals will be older than years or be post menopausal females and BMD assessment will therefore be indicated if they have not had this determined in the previous two years