# Quantitative Ultrasound To Diagnose Nonalcoholic Fatty Liver Disease in Children.

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2024 · $703,391

## Abstract

SUMMARY
Our broad long-term objective is to improve the health of children with nonalcoholic fatty liver disease (NAFLD),
a condition characterized by accumulation of fat in liver cells, by developing and validating accurate, precise,
practical, and widely available tools to detect, measure, and monitor liver fat. Over 5 million American children
have NAFLD, placing them at risk for type 2 diabetes, cirrhosis, and premature death. Addressing this health
crisis is crucial for our nation. Clinical practice guidelines recommend screening for NAFLD in American children
aged 9 to 17 years with overweight or obesity because early diagnosis, prompt specialist referral, and NAFLD-
tailored management can improve outcomes. However, there is no accurate, precise, practical, and widely
available diagnostic tool to implement these guidelines, a major unmet need in pediatric NAFLD. Quantitative
ultrasound (QUS, US) holds promise to address this unmet need, but notable gaps in QUS technology persist:
Gap 1) unsatisfactory accuracy of current commercial QUS methods for estimating liver fat content in children;
Gap 2) availability of commercial QUS technology mainly on full-size (US) systems, primarily located within
radiology departments, limiting access for many children at risk NAFLD; and Gap 3) poor cross-vendor
reproducibility, which undermines utility. Our immediate goal is to address these gaps by developing advanced
QUS analysis models for use with full-size US or inexpensive POCUS systems in children at risk for NAFLD to
estimate liver fat fraction and classify presence/absence of fatty liver. The models will incorporate technical
innovations to improve QUS accuracy and efficiency. To develop and test these models, we propose a cross-
sectional accuracy and precision clinical study in 140 children (ages 9 to 17 years) suspected to have NAFLD,
who will undergo full-size US and POCUS exams with contemporaneous MRI-proton density fat fraction as
reference. Our three specific aims are: Aim 1. To improve accuracy of QUS on full-size US for liver fat
assessment in children. Aim 2. To translate QUS liver fat assessment in children to POCUS. Aim 3. To improve
cross-vendor reproducibility of QUS liver fat assessment in children. We hypothesize that our QUS models using
either full-size US or POCUS will estimate liver fat content more accurately than other US methods. We also
expect our models to classify presence/absence of fatty liver in children more accurately than other US methods.
Exploratory aims are to: a) explore associations between QUS and histology; b) explore effects of potential
confounders on accuracy and precision of QUS models; c) create a repository of US data, plasma, and digitized
histology for future research. Impact: Achieving our study aims will enable multi-center, multi-vendor trials, which
collectively have the potential to transform clinical practice and therapeutic discovery in children by enabling
widespread dissemination of reliable,...

## Key facts

- **NIH application ID:** 10882535
- **Project number:** 1R01DK135951-01A1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** CLAUDE B SIRLIN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $703,391
- **Award type:** 1
- **Project period:** 2024-07-01 → 2029-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10882535

## Citation

> US National Institutes of Health, RePORTER application 10882535, Quantitative Ultrasound To Diagnose Nonalcoholic Fatty Liver Disease in Children. (1R01DK135951-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10882535. Licensed CC0.

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