Ultrasound-coupled Electrical Impedance Tomography for Sarcopenia Assessment

用于肌肉减少症评估的超声耦合电阻抗断层扫描

• 批准号: 10760707
• 负责人: Ryan Joseph Halter
• 金额: $ 27.58万
• 依托单位: RYTEK MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10760707
• 关键词: Affect; Algorithms; Animal Model; Animals; Biological Markers; Biometry; Blood flow; Breast Cancer Patient; Breast Cancer Treatment; Businesses; Cessation of life; Clinic; Clinic Visits; Clinical; Clinical Research; Clinical Trials; Communities; Complement; Computer software; Coupled; Couples; Data; Devices; Diagnosis; Diagnostic; Disease; Disease Progression; Electrodes; Electromagnetics; Evaluation; Face; Family suidae; Fatty acid glycerol esters; Fibrosis; Functional disorder; Funding; Future; Geometry; Health; Heterogeneity; Hospitalization; Housing; Image; Imaging Device; Imaging Phantoms; Individual; Industrialization; Infiltration; Inflammation; Intramuscular; Magnetic Resonance Imaging; Manufacturer; Maps; Marketing; Measurement; Medical; Methods; Modality; Muscle; Muscular Dystrophies; Musculoskeletal Diseases; Myopathy; Neurofibromatoses; Neuromuscular Diseases; Noise; Output; Patient Care; Patients; Persons; Phase; Physiological; Population; Positioning Attribute; Procedures; Property; Protocols documentation; Reference Standards; Research; Risk; Saline; Skin; Small Business Technology Transfer Research; Standardization; Structure; Surgical complication; System; Technology; Time; Tissues; Toxic effect; Toxicity due to chemotherapy; Translating; Treatment Efficacy; Ultrasonography; Woman; chemotherapy; clinical application; college; commercialization; compliance behavior; cost effective; data acquisition; design; diagnosis standard; diagnostic biomarker; diagnostic criteria; diagnostic tool; electric impedance; electrical impedance tomography; electrical property; feasibility trial; human study; image reconstruction; imaging modality; imaging properties; improved; individual patient; individualized medicine; malignant breast neoplasm; manufacture; muscle form; new technology; novel; novel therapeutics; personalized medicine; portability; premature; quantitative imaging; sarcopenia; sarcopenic obesity; simulation; subcutaneous; tool; ultrasound

PROJECT SUMMARY/ABSTRACT Clinical Need: The coming decades promise a revolution in the personalized treatment for patients with breast cancer, including approaches to minimize collateral damage of curative. However, to help facilitate this, the academic and industrial clinical research communities need improved diagnostic biomarkers to assess the presence of muscle diseases such as sarcopenia. Once these diagnostic markers become available, these tools will be needed to help to tailor therapy to the needs of individual patients. Limitations: Current approaches for evaluating sarcopenia are very limited, with modest sensitivity and uncertain reliability. These methods typically include simple force measurements, or imaging with MRI, CT or ultrasound (US). For example, force measurements require patient cooperation making them very subject dependent with low reliability. CT is considered the reference standard for assessing sarcopenia; however, it is not obtained in patients with early-stage breast cancer. MRI is very expensive and not able to be performed in a routine clinic visit. Finally, US is extremely convenient since it can be used directly in the clinic, however, it is qualitative and very challenging to perform meaningful quantitative image assessment. Our Product – Ultrasound-coupled Electrical Impedance Tomography (US-EIT) is an electrical property imaging device that integrates with a standard ultrasound probe to provide augmented US imaging. Similar to Doppler imaging for blood flow mapping, our device will be able to be ‘flipped on’ to provide a map of the electrical properties of the underlying muscle tissue. Electrical properties of muscle have been shown by our group and others to be sensitive to tissue properties reflecting muscle health, and has recently been found to be sensitive to inflammation; however, this approach is a single local measurement and provides no spatial information regarding muscle pathophysiology. We plan to combine for the first time ever in a commercial setting, electrical impedance imaging with standard US for assessing sarcopenia. We hypothesize that this device will be sufficiently sensitive and specific so as to provide a highly reliable output on muscle health. Specific Objectives: We specifically propose to design a sonolucent electrode array and housing that seamlessly integrates to a standard US probe. Secondly, we will evaluate our technology’s repeatability and ability to evaluate muscular variability (i.e., distinguish levels of intramuscular fatty infiltration and inflammation) in a small feasibility trial in pigs. Future Directions: RyTek Medical is a small company developing bioimpedance-sensing devices for a variety of clinical applications. This device will complement our existing efforts. By the end of this Phase 1 effort, we will have demonstrated that the US-EIT probe is functional in an animal population, and we will have provided evidence that this approach can distinguish quantify physiological markers of sarcopenia. This will position us for Phase 2 funding focused on conducting a clinical trial aimed at assessing sarcopenia prior to breast cancer treatment and preparing for a 510(k) or IDE application to the FDA.

项目总结/文摘