Portable Quantitative Ultrasound with DXA/QCT and FEA Integration for Human Longitudinal Critical Bone Quality Assessment

Project Overview: Skeletal complications, i.e., osteoporosis, induced by microgravity during extended space missions represent a key astronaut health problem. Lack of on-board diagnosis has increased significant risk in astronauts' bone loss during long term space flight. Early diagnosis of such disorders can lead to prompt and optimized treatment that will dramatically reduce the risk of fracture and longitudinal monitoring microgravity and countermeasure effects. Advents in quantitative ultrasound (QUS) techniques provide a method for characterizing the material properties of bone in a manner for predicting both BMD (bone mineral density) and mechanical strength. We have developed a scanning confocal acoustic navigation (SCAN) system capable of generating noninvasive ultrasound images at the site of interest. Both animal and human tests indicated strong correlations between SCAN determined data and microCT determined BMD, and bone strength, as well as monitoring fracture healing with guided ultrasound. The objectives of this study are to develop a portable broadband SCAN for critical skeletal quality assessment, to monitor bone alteration in disuse osteopenia, and to integrate ultrasound with DXA for human subject in multiple skeleton sites. In vivo human tests are evaluated at Stony Brook Osteoporosis Center. Human cadaver and animal samples will be used for testing feasibility of identifying bone loss, microstructural and mechanical strength properties. Development of a noninvasive diagnostic and treatment technology using noninvasive ultrasound with new crystal transducer technology will have a great potential to perform longitudinal measurement of bone alteration and prevent the risk of fracture.

Technical Summary: Non-invasive assessment of trabecular bone strength and density is extremely important in predicting the risk of fracture in space and ground operation. Quantitative ultrasound (QUS) has emerged with the potential to directly detect trabecular bone strength. To overcome the current hurdles such as soft tissue and cortical shell interference, improving the quality of QUS and applying the technology for future clinical applications, this phase of the development of image based SCAN system will concentrate on several main areas: (1) increasing the resolution, sensitivity, and accuracy in diagnosing osteoporosis through confocal acoustics to improve signal/noise ratio, and through extracting surface topology to accurately calculate ultrasound speed of sound; (2) minimizing the scanning time while maintaining reasonable resolution via micro-processor controlled and phased array electronic confocal scanning, e.g., in deep bone tissue scan; (3) developing broadband ultrasound system to measure deep bone tissue density and structural parameters in the critical regions; (4) developing hardware and software interface with flexible ultrasound platform (FUS), and therapeutical ultrasound for acceleration of fracture healing; (5) assessment of the capability of the SCAN system of imaging scan for human wrist and calcaneus for bone density assessment in normal and osteoporosis subjects. The proposed work will develop a portable rapid SCAN system combined with imaging capability, and test its efficacy in human, which will ultimately provide a portable, noninvasive device for bone loss assessment in space.

Earth Applications: Skeletal decay complications are major health problems on Earth, i.e., osteoporosis, and delayed healing of fractures. Development of a low mass, compact, noninvasive diagnostic and treatment technology, i.e., using ultrasound, will have a great potential to prevent and treat bone fracture. Our principal goal is to develop a portable quantitative ultrasound system with therapeutic capability, not only for determination of bone's physical properties, but also for predicting subtle changes of bone during extended flights and diseased condition, which will impact both diagnosis and noninvasive treatment for musculoskeletal disorders. Use of a desktop based non-ionizing bone assessment device has great clinical applications as an in-office quantitative assessment of fracture risk in the general and at-risk populations.

Key findings and milestones: In this study, the team is able to continue development of a scanning confocal acoustic diagnostic combined with therapeutic system capable of generating acoustic images at the regions of interest for identifying the strength of trabecular bone with high-resolution QUS attenuation and velocity maps, and thus determining the relationship between ultrasonic parameters and bone mineral density (BMD), and bone's physical properties, as well as providing treatment for fracture healing. Ultrasound has been used in an OVX (ovariectomy) and femur fracture animal model to mitigate bone loss and acceleration of fracture healing. Phase array transducer and system are built and successfully tested in initial normal control and osteoporotic human subjects in multiple skeletal sites. The team is able to work with TRS Transducers, Inc. for evaluation of a wideband frequency ultrasound transducers in range of 0.5MHz - 7.0MHz, and with GE Research Center for flexible ultrasound platform (FUS) system in system requirement specifics, user-interface software evaluation and 2-D array transducer design. The results have shown that ultrasound can mitigate bone loss and promote fracture healing under disuse osteopenia condition.

Musculoskeletal decay due to a microgravity environment has greatly impacted the nation's civil space missions and ground operations. Such musculoskeletal complications are also major health problems on Earth, i.e., osteoporosis, and the delayed healing of fractures. About 13 to 18 percent of women aged 50 years and older and 3 to 6 percent of men aged 50 years and older have osteoporosis in the US alone. One-third of women over 65 will have vertebral fractures and 90% of women aged 75 and older have radiographic evidence of osteoporosis. Thus, approximately a total of 28 million people suffer from osteoporosis in the United States, with an estimated annual direct cost of over $30 billion to national health programs. Hence, an early diagnosis that can predict fracture risk and result in prompt treatment is extremely important. Ultrasound has also demonstrated its therapeutic potentials to accelerate fracture healing. The objectives of this study are focused on developing a combined diagnostic and treatment ultrasound technology for early prediction of bone disorder and guided acceleration of fracture healing, using SCAN imaging and low-intensity pulse ultrasound. Development of a low mass, compact, noninvasive diagnostic and treatment modality will have great impacts as early diagnostic to prevent bone loss and accelerate fracture healing. This research will address critical questions in the Bioastronauts Roadmap related to non-invasive assessment of the acceleration of age-related osteoporosis and the monitoring of fractures and impaired fracture healing. The results have demonstrated the feasibility and efficacy of SCAN for assessing bone's quality in bone. We have been able to demonstrate that the bone quality is predictable via non-invasive scanning ultrasound imaging in the region of interests (ROI), and to demonstrate the strong correlation between SCAN determined data and microCT identified BMD, structural index, and mechanical modulus. These data have provided a foundation for further development of the technology and the clinical application in this research.

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