Evaluation of non-contrast-enhanced Magnetic Resonance Imaging compared to standard of care ultrasound for hepatocellular cancer surveillance in patients with liver cirrhosis
Every six months, 300 patients with liver cirrhosis will undergo both a standard ultrasound and a new, contrast-free MRI scan to see which catches early-stage liver cancer more reliably. Liver cancer is the third leading cause of cancer death globally, and in the UK cases are rising. Most liver cancers develop in patients with cirrhosis, who are offered ultrasound surveillance every six months. But ultrasound often misses early tumours—especially in patients with obesity or fatty liver disease—when curative treatment is still possible. This study directly compares ultrasound with an abbreviated non-contrast-enhanced MRI (nceMRI) protocol, which takes less time than a full MRI and does not require an injected dye. If nceMRI proves more accurate at detecting early hepatocellular carcinoma, it could replace ultrasound as the standard surveillance tool for high-risk cirrhosis patients. That would mean more cancers caught early enough to treat with curative intent, and fewer patients progressing to advanced disease. The study also includes a mechanistic sub-study that analyses quantitative MRI data from the “background” liver tissue, looking for imaging features that signal a pro-carcinogenic field effect. These insights could feed into new risk algorithms, improving how surveillance is targeted. The results will inform a future randomised trial on whether nceMRI-based surveillance actually improves survival.
View original technical description
Background Hepatocellular carcinoma (HCC), the most common cause of primary liver cancer, is the 3rd leading cause of cancer death globally. In the UK, HCC incidence has been increasing and predicted to rise further. The vast majority of HCC arise in patients with liver cirrhosis. Surveillance for HCC in patients with cirrhosis is dependent on liver ultrasound scan (USS) performed every 6 months. However, liver USS has low sensitivity for the detection of early HCC (HCC that can be treated with curative intent) and does not perform consistently across the population under surveillance; ultrasound is particularly difficult in patients with obesity and fatty liver disease. In this study we plan to evaluate an abbreviated non-contrast-enhanced liver magnetic resonance imaging (nceMRI) protocol, and compare it to standard-of-care ultrasound for the detection of early HCC in patients with cirrhosis at high risk of developing HCC. The study will leverage patients with cirrhosis, recruited to a CRUK Early Detection programme across the UK, and identified as having high risk of developing HCC using a validated risk score (aMAP) based on clinical and biochemical parameters. Aims and objectives To compare the diagnostic accuracy of an abbreviated liver nceMRI protocol and liver USS for the diagnosis of early HCC in patients with cirrhosis at high risk of developing HCC undergoing surveillance. Methods This will be a prospective, multicentre study in 300 patients with cirrhosis at high risk of developing HCC. Each patient will undergo six rounds of 6-monthly surveillance with liver USS and nceMRI. The study will comprise three stages: Stage 1: Conduct a feasibility pilot study to collect USS and nceMRI data on the baseline scans from the first 90 patients with cirrhosis across 10 sites; Stage 2: Continue recruitment to complete the full study in 300 patients with cirrhosis in up to 30 sites; Stage 3: Complete a mechanistic sub-study of the quantitative data from nceMRI scans collected in Stage 1 and 2 in all patients. This will assess changes in the “background” liver (liver tissue not affected by HCC tumour in those who develop HCC or any part of the liver in those without HCC) that may be associated with a pro-carcinogenic “field effect” in the cirrhotic liver. Timeline for delivery March 2024 (M1): Grant commences. June 2025 (M15): Completion of Stage 1, review of Stop/Go criteria. July 2025 (M16): Stage 2 and Stage 3 commence if Go criteria are met. Sep 2028 (M54): USS/nceMRI follow-up of 300 patients and USS/nceMRI clinical reporting complete. Dec 2028 (M57): Analysis of quantitative nceMRI data for the mechanistic sub-study is complete. Feb 2029 (M60): Statistical analysis complete, and future planning for randomised controlled trial. Anticipated impact and dissemination We will determine the feasibility and diagnostic accuracy of abbreviated nceMRI used as a surveillance tool for detection of early HCC in patients with cirrhosis and high risk of HCC. We will give new mechanistic insights into features of liver cirrhosis, characterised using quantifiable imaging data of the background liver parenchyma, that may lead to HCC transformation, and that may be included in new algorithms to drive innovations in HCC detection strategies. Data from this study will inform a larger randomised study to assess whether using nceMRI in HCC surveillance approaches that are applicable to all patients with cirrhosis improves survival.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know