Approximately 37M people in the USA are affected by chronic kidney disease (CKD), and it is the 9th leading cause of death in the USA. Complications resulting from CKD are common, and the disease is an enormous financial burden for the US health care system. Despite substantial efforts of investigators around the country, a pharmaceutical treatment to directly reverse the process of fibrosis (a key physiological process in CKD) and regenerate nephrons has remained elusive. The demand for novel therapeutics is only expected to grow. Animal models are the gold standard for basic and applied kidney disease research, but there are no widely used noninvasive imaging tools for assessing renal fibrosis within these models; this represents a major limitation in the kidney disease research and drug development fields. The work proposed herein will result in a platform that will dramatically accelerate the pace of basic and applied research in CKD. SonoVol is proposing to build and validate a novel renal fibrosis imaging platform and validate it against both in vivo and ex vivo gold standards. The prototype system will be deployed within SonoVol?s VegaTM platform, a robotically controlled volumetric scanning device for high-throughput rodent imaging. This will remove existing bottlenecks and ensure accurate and repeatable renal fibrosis measures. This work will proceed via three stages: First, we will develop hardware to allow accurate and repeatable sampling of ultrasound elastography images by adding a rotational degree of freedom, enabling long and short axis measurements regardless of how a kidney is positioned. Second, we will develop software to facilitate automated kidney localization and acquisition of multiple ultrasound stiffness mapping modes to allow fibrosis to be evaluated whether or not a kidney contains fluid filled cysts. Finally, we will validate the platform using in vitro phantoms and then two different in vivo models for renal fibrosis. The data will be compared to gold standards for both in vivo and ex vivo readouts.

Public Health Relevance

Approximately 37M people in the USA are affected by chronic kidney disease (CKD), and it is the 9th leading cause of death in the USA. The demand for novel therapeutics is only expected to grow. Animal models are the gold standard for basic and applied kidney disease research, but there are no widely used noninvasive imaging tools for assessing renal fibrosis within these models. The work proposed herein will solve this problem. SonoVol, in collaboration with the Mayo Clinic, is proposing to build and validate a novel renal fibrosis imaging platform and validate it against both in vivo and ex vivo gold standards.

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 #
1R43DK126607-01A1
Application #
10154589
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Gossett, Daniel Robert
Project Start
2020-09-15
Project End
2021-08-31
Budget Start
2020-09-15
Budget End
2021-08-31
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Sonovol, Inc.
Department
Type
DUNS #
078519223
City
Durham
State
NC
Country
United States
Zip Code
27709