Liver fibrosis, a hallmark of many liver diseases, affects millions of people in America every year, and annually kills tens of thousands of these patients. Despite very active research efforts, there still have been no specific antifibrotic drugs approved by the FDA. The liver disease and drug development communities do not currently have well-validated, low-cost, easy to use, noninvasive tools for studying liver fibrosis in preclinical rodent models making it challenging to execute high-quality longitudinal studies. To address this need, SonoVol Inc. proposes to develop a novel benchtop imaging system capable of providing rapid, noninvasive measurements of liver fibrosis in rodents with robotically-controlled shear wave elasticity imaging (SWEI). In SWEI, ultrasound pulses are used to generate shear waves in an organ an interest, and tissue stiffness can be inferred by monitoring the speed of the travelling waves. SWEI technology has been very successful in clinical trials and is starting to be adopted by abdominal radiology clinics around the world as a replacement for liver biopsy. While some preclinical SWEI products exist on the market today, all of them follow the conventional ultrasound paradigm of data collection ? a trained sonographer uses a handheld probe and manually selects regions of interest to interrogate with SWEI. Making consistent and accurate measurements requires in depth knowledge of probe placement and sonographic technique, which academic biologists or drug researchers are unlikely to possess. Therefore, SonoVol will develop a device capable of fully-automated, non-contact SWEI that eliminates the need for a trained sonographer and will enable large scale adoption of this powerful technology in the preclinical liver diseases research community. To validate the new system, two different animal models for hepatic fibrosis will be evaluated, and the results compared to conventional postmortem assessments of liver fibrosis. This technology represents an innovative combination of a widefield 3D robotic ultrasound imaging system and noninvasive shear wave elastography. Furthermore, the technology can be applied in the future to many other diseases, including cancer or cardiac models, increasing the potential market and impact on the field.

Public Health Relevance

There are many methods currently used by researchers to collect images of preclinical rodent anatomy and internal organ function. However, these technologies are rarely used by the liver fibrosis research and drug development communities due to their cost or technical complexity. We are proposing to build the first automated low-cost benchtop noninvasive liver fibrosis measurement tool to be used in rodent research. In the future, our benchtop imaging product will help reduce the financial burden and increase the pace of preclinical liver disease and drug studies by leveraging lower-cost hardware and an automated approach to analyzing tissue stiffness.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DK112492-01
Application #
9255098
Study Section
Special Emphasis Panel (ZRG1-SBIB-T (10)B)
Program Officer
Densmore, Christine L
Project Start
2016-09-20
Project End
2017-09-19
Budget Start
2016-09-20
Budget End
2017-09-19
Support Year
1
Fiscal Year
2016
Total Cost
$225,009
Indirect Cost
Name
Sonovol, LLC
Department
Type
DUNS #
078519223
City
Chapel Hill
State
NC
Country
United States
Zip Code
27514