# CONTRAST-ENHANCED ULTRASOUND EVALUATION OF FOCAL LIVER LESIONS IN PATIENTS WITH CIRRHOSIS OR OTHER RISK FACTORS FOR DEVELOPING HCC

> **NIH NIH R01** · THOMAS JEFFERSON UNIVERSITY · 2020 · $519,465

## Abstract

Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide with an annual
incidence of over 550,000, predominantly affecting patients with cirrhosis and chronic hepatitis.
Current American Association for the Study of Liver Diseases (AASLD) practice guidelines
recommend ultrasound (US) for HCC surveillance, and CT and MRI for diagnosis of HCC in
patients with nodules detected by surveillance US. Contrast-enhanced ultrasound (CEUS) has
been extensively studied for liver imaging. Multiple pilot and single-institution studies have
demonstrated high specificity and positive predictive value of CEUS for HCC diagnosis,
comparable to hepatobiliary agent gadoxetate-enhanced MRI. Based on that, World Federation
of Ultrasound in Medicine and Biology and European Federation of Societies for Ultrasound in
Medicine and Biology in their joint guidelines recommended use of arterial phase
hyperenhancement with contrast washout on CEUS to diagnose HCC. However it has not been
tested in a multicenter setting in patients at risk for HCC. A recent development that has the
potential to improve clinical acceptance of CEUS is the introduction of the CEUS Liver Imaging
Reporting and Data System (CEUS LI-RADS) introduced by the American College of Radiology.
This system provides standardization of CEUS examination, imaging findings and reporting, and
allows liver nodule classification based on their likelihood to be HCC. However, this system has
not been clinically validated. We hypothesize that the high diagnostic value of CEUS for HCC
diagnosis will be confirmed in a multicenter setting, providing a safe and accurate imaging
technique for focal liver nodule characterization, including in patients with contraindications to
CT and/or MRI, such as such as allergic reactions to contrast, claustrophobia, metallic implants
or foreign bodies or renal insufficiency. In addition, we hypothesize that use of CEUS LI-RADS
will decrease user-dependency of CEUS. A total of 640 patients will be included in this
international multicenter study. All patients will receive CEUS and results will be compared to a
rigorous composite imaging and tissue histology reference standard to determine the diagnostic
value of CEUS for HCC diagnosis clinical validity of CEUS LIRADS classification. This project
will also establish user-dependency of CEUS and address factors that might potentially limit its
clinical use.

## Key facts

- **NIH application ID:** 10007766
- **Project number:** 5R01CA215520-04
- **Recipient organization:** THOMAS JEFFERSON UNIVERSITY
- **Principal Investigator:** Andrej Lyshchik
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $519,465
- **Award type:** 5
- **Project period:** 2017-09-15 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10007766

## Citation

> US National Institutes of Health, RePORTER application 10007766, CONTRAST-ENHANCED ULTRASOUND EVALUATION OF FOCAL LIVER LESIONS IN PATIENTS WITH CIRRHOSIS OR OTHER RISK FACTORS FOR DEVELOPING HCC (5R01CA215520-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10007766. Licensed CC0.

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