# Ultrasound-Based Device to Guide Treatment of Graft-Versus-Host-Disease using Skin Elasticity as a Biomarker

> **NIH NIH R42** · MICROELASTIC ULTRASOUND SYSTEMS, INC. · 2020 · $770,507

## Abstract

Ultrasound-Based Device to Guide
Treatment of Graft-Versus-Host-Disease
using Skin Elasticity as a Biomarker
1 ABSTRACT
Sclerotic chronic graft versus host disease (cGVHD) develops in 30 - 70% of allogenic Human Stem Cell
Transplant (HCT) recipients and is associated with significant morbidity and mortality. GVHD is treated with
immunosuppression, which puts patients at severe risk of infection. Immunosuppression must therefore be
delivered judiciously to obtain the therapeutic effect while minimizing dose, but current clinical instruments for
quantifying cGVHD provide an incomplete picture and are not sensitive enough to predict outcome or response
to therapy[1], [2]. Currently, there is no standard device used to measure skin sclerosis in clinical
practice. Indeed, the NIH Chronic GVHD Working Group has stated that: “There is an urgent need for the
development of more quantifiable and reproducible measurements or imaging methods that could be used in
patients with sclerotic skin manifestations of chronic GVHD”[3]
Our team includes the inventors of ultrasound-based methods for measuring the elasticity of tissue[4], which
we have demonstrated to distinguish healthy skin from sclerotic in preliminary clinical studies using our
research platform[5]. We have invented a specific type of elasticity measurement called Constructive
Shearwave Interference (CSI), optimized for use in portable, point-measurement systems without the
complexity and cost of full-scale clinical imaging systems, and with features to improve estimates in highly
sclerotic skin over previous methods.
In Phase I, we built the first dedicated CSI transducers and systems, developed the software and algorithms to
quantify the elasticity of thin-layered media, and characterized their performance in tissue-mimicking elastic
phantoms. We demonstrated that all of the necessary ultrasound electronics could be built into a single device,
controlled by USB. We have benchmarked the performance of these devices with simulations and experiments
and designed and built a system for assisting with positioning the transducer a fixed distance from the skin and
detecting proper alignment. In summary, the progress we have made in Phase I to answer critical feasibility
questions has us well-positioned for success in Phase II.
In Phase II, we propose to prepare our prototype devices for use in a clinical study by developing important
features and performing critical safety analysis and testing, both in the context of this study, and in preparation
for submission to the FDA. Based on findings of the simulations and experiments, we also propose to develop
advanced algorithms for robust estimation of skin properties, including automatic detection of skin thickness.
This leads up to our major goal, which is to perform a clinical study to test our technology’s reliability at
identifying disease severity in comparison to invasive gold-standards.
With successful completion of the tasks proposed in Phase II, we...

## Key facts

- **NIH application ID:** 9910381
- **Project number:** 5R42CA228159-03
- **Recipient organization:** MICROELASTIC ULTRASOUND SYSTEMS, INC.
- **Principal Investigator:** Adela Rambi Cardones
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $770,507
- **Award type:** 5
- **Project period:** 2017-09-15 → 2022-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9910381

## Citation

> US National Institutes of Health, RePORTER application 9910381, Ultrasound-Based Device to Guide Treatment of Graft-Versus-Host-Disease using Skin Elasticity as a Biomarker (5R42CA228159-03). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/9910381. Licensed CC0.

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