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3D Shearwave Elasticity Biomarker Development for Neuromuscular Disease

神经肌肉疾病的 3D 剪切波弹性生物标志物开发

基本信息

批准号：
10601107
负责人：
Kathryn Radabaugh Nightingale
金额：
$ 54.15万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-04-01 至 2025-12-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10601107
关键词：
3-Dimensional Acoustics Adoption Affect Age Algorithms Anisotropy Behavior Biological Markers Biomechanics Biopsy Breast Calibration Cessation of life Clinic Clinical Clinical Research Clinical Trials Complex Consumption Data Diagnosis Disease Disease Management Disease Progression Dual-Energy X-Ray Absorptiometry Duchenne muscular dystrophy Elastic Tissue Elasticity Exclusion Fiber Gender Geometry Glycogen storage disease type II Health Height Heterogeneity Image Imaging technology Isotropy Lesion Liver Fibrosis Magnetic Resonance Imaging Measurement Measures Medical Methods Modeling Modulus Monitor Muscle Muscle Fibers Muscle function Muscular Dystrophies Musculoskeletal Musculoskeletal System Myopathy Nature Neuromuscular Diseases Outcome Measure Pain Pathology Patient Participation Patients Performance Procedures Property Prostate Radiation Replacement Therapy Reporting Research Risk Sampling Scanning Skeletal Muscle Speed Staging System Testing Therapeutic Therapeutic Intervention Thyroid Gland Time Treatment Efficacy Ultrasonics Ultrasonography Viscosity Walking Weight X-Ray Computed Tomography biomarker development biomechanical test comorbidity compliance behavior cost data acquisition disability disease diagnosis efficacy evaluation elastography enzyme therapy gene therapy image reconstruction imaging approach imaging modality imaging system improved in vivo mechanical properties muscle strength novel novel therapeutics personalized medicine portability primary outcome prototype reconstruction screening sex side effect skeletal disorder soft tissue success tool treatment response ultrasound viscoelasticity

项目摘要

Neuromuscular disorders, including Duchenne's Muscular Dystrophy and Pompe disease, are progressive and often result in signiﬁcant disability and sometimes death. Encouragingly, novel enzyme replacement and ge- netic therapies are becoming available, but they are associated with detrimental side effects and assessing their efﬁcacy remains a challenge. Current methods used to assess muscle health are subjective, non-quantitative, and focus on muscle quantity and strength; however, measuring muscle quantity can over-estimate the amount of functional muscle, and muscle strength tests are affected by patient cooperation, pain, and co-morbidities. There is an urgent and unmet clinical need for a low-cost, non-invasive biomarker to accurately assess muscle health, monitor disease progression, and determine treatment response. Ultrasonic shear wave elasticity (SWE) imaging methods estimate the biomechanical properties of soft tissues, and these methods have demonstrated promise in the characterization of healthy and diseased muscle; however, commercially- available SWE methods are limited to estimating material parameters from a 2D imaging plane, and measure- ment variability and challenges with ﬁber alignment have limited clinical adoption. We have developed a 3D- SWE imaging system and advanced reconstruction algorithms with which we have obtained preliminary in vivo data that demonstrate, for the ﬁrst time, the complex 3D shearwave behaviors generated by SWE excitations in vivo in skeletal muscles, and have observed signiﬁcant differences between patients with myopathy that are consistent with clinical strength metrics. We have developed reconstruction algorithms that leverage the 3D-nature of these data to estimate multiple independent material properties, including: the longitudinal and transverse shear moduli, the shear anisotropy, the tensile anisotropy, and the viscosity along and across the muscle ﬁbers. We hypothesize that the more complete material characterization afforded by these measurements will provide improved biomarkers of muscle health. We now propose to optimize the se- quencing and minimize the 3D data acquisition time; to automate and validate our parameter reconstruction al- gorithms; and to quantify the parameter measurement accuracy and precision in calibrated elasticity phantoms. Finally, we propose a pilot clinical study in which we will quantify and compare 3D-SWE muscle parameters in vivo in patients with myopathy and muscular dystrophy and in healthy controls, evaluate the repeatability of these measurements, and assess their correlation with clinical measures of muscle health. Successful com- pletion of this project will provide non-invasive quantitative biomarkers of muscle health on a low-cost portable platform, enabling frequent measurement and longitudinal monitoring of disease progression and treatment response which will facilitate personalized and optimized neuromuscular disease man- agement.

神经肌肉疾病，包括杜氏肌营养不良症和庞贝病，是进行性的