Ultrasound-coupled Electrical Impedance Tomography for Sarcopenia Assessment

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.