Microelastic Ultrasound Systems, Inc. — Department of Health and Human Services SBIR Phase I: 102

Description

Abstract For patients undergoing lymph node dissection and/or radiation therapy for the treatment of cancer, there is a lifetime risk of developing lymphedema. This disease causes swelling of the extremities and motor impairment, and is a lifelong condition without a cure. For the 21-75% of cancer survivors who develop the disease, managing lymphedema costs the US healthcare system approximately $2,400 annually per patient.1 Early detection of lymphedema and subsequent monitoring of treatment impact is highly consequential of patient outcomes. According to the 2016 Consensus Document of the International Society of Lymphology, “An accurate diagnosis of lymphedema is essential for appropriate therapy” and emphasized the need to “shift the focus to a more proactive rather than reactive approach.”2 There is currently no gold standard for diagnosing lymphedema and monitoring its progression4. Common measures - such as limb volume, arm circumference, and qualitative assessments - suffer from lack of practicality, precision, and consistency between clinicians. We have invented an ultrasound device that quantifies dermal elasticity with self-amplifying shear waves in the skin. Initial clinical data have shown great potential for noninvasively staging skin sclerosis using such methods, and the underlying technology enables commercialization of a portable, easy-to-use solution for a variety of clinical settings including the management of lymphedema. Since lymphedema involves swelling, it causes pressure buildup in surrounding tissue, pulling the overlying skin more tightly. This tightness can be directly measured by our device and therefore serves as a potential biomarker for lymphedema. We propose to adapt our device for the detection of lymphedema by incorporating subcutaneous tissue and viscoelasticity modeling, as well as conducting a clinical study comparing our device to conventional methods. Successful completion of these aims will allow us to submit for 510(k) clearance from the FDA, enable researchers to better study lymphedema, and make this technology available to clinicians. By enabling convenient and precise quantification of lymphedema using skin elasticity as a biomarker, clinicians may be able to better detect and manage lymphedema, enhance patient compliance by demonstrating the impact of self-care, and thereby improve long-term outcomes.Project Narrative Detecting and monitoring lymphedema is critical to long term management of patients following lymph node dissection and/or radiation treatment, but current methods lack the required precision, repeatability, and convenience to detect the disease before symptoms present. Our novel ultrasonic device measures skin elasticity instantly and noninvasively, and early testing in other skin applications indicate it may be a useful objective measure for quantifying the disease in a clinical setting. In preparation for regulatory clearance by the FDA, we propose to adapt the device for use in lymphedema management, and evaluate its correlation with conventional measures in a clinical study.