# Development of a Novel MRI Contrast Agent for Early Detection of Alcoholic Steatohepatitis

> **NIH NIH UT2** · INLIGHTA BIOSCIENCES, LLC · 2020 · $989,930

## Abstract

Abstract
Chronic liver disease (CLD) is a major cause of morbidity and mortality worldwide[1-4]. Hepatic fibrosis can
develop in patients with any type of chronic liver disease (CLD), including alcoholic liver disease (ALD), hepatitis
C, hepatitis B, nonalcoholic fatty liver disease (NAFLD) and autoimmune hepatitis. The major clinical
consequences of cirrhosis are liver failure and hepatocellular carcinoma (HCC), both of which increase the risk
of death. Alcoholic liver disease (ALD) is a leading cause of liver disease and liver-related deaths globally,
particularly in developed nations. The current gold standard diagnostic method, liver biopsy is invasive and has
many limitations including sampling error and high inter-observer variability even for the diagnosis of advanced
stages of liver fibrosis. None of several technologies investigated as alternatives offers the desired sensitivity
and specificity for the early detection and staging of fibrosis. Thus, an innovative, safe MRI contrast agent is
required to overcome several major limitations including low sensitivity and specificity for early stage fibrosis and
detection in heterogeneous tissue. Our team has pioneered a new class of gadolinium based contrast agents
which utilize a protein scaffold to bind Gd3+ atoms. We have shown that ProCA32.collagen, a collagen 1 targeted
protein MRI contrast agent, exhibits strong affinity to collagen I, whose expression level and spatial pattern
depend on the stage of fibrosis. ProCA32.collagen possesses high relaxivities per particle (r1 and r2) at both 1.4
and 7.0 T, which enables the robust detection of early-stage alcohol-induced liver fibrosis and nonalcoholic
steatohepatitis in animal models via dual contrast modes. Our preliminary studies on toxicity profiles and in vivo
stability of our compound in animals using non-GLP grade materials have provided confidence that the
compound will exhibit good sensitivity and specificity for early detection of liver fibrosis in human clinical trials.
In Phase I of this proposal, we seek timely support for conducting IND enabled CMC studies for generating
GLP/cGMP grade ProCA32.collagen. In Phase II, we will conduct toxicity and safety profile studies using
GLP/cGMP grade products to complete IND required studies for clinical trials.

## Key facts

- **NIH application ID:** 10065310
- **Project number:** 1UT2AA028659-01
- **Recipient organization:** INLIGHTA BIOSCIENCES, LLC
- **Principal Investigator:** Jenny J. Yang
- **Activity code:** UT2 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $989,930
- **Award type:** 1
- **Project period:** 2020-09-20 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10065310

## Citation

> US National Institutes of Health, RePORTER application 10065310, Development of a Novel MRI Contrast Agent for Early Detection of Alcoholic Steatohepatitis (1UT2AA028659-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10065310. Licensed CC0.

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