About this trial
Ultrasound (US) used for hepatocellular carcinoma (HCC) surveillance suffers from low sensitivity (60-78%) due to fatty liver, obesity, and diffusely nodular appearance in cirrhosis. Once a suspicious malignant lesion is detected at US, guidelines recommend contrast-enhanced US, magnetic resonance imaging (MRI) or computed tomography (CT) scans to confirm suspicion. The investigators' team has developed innovative quantitative US (QUS) techniques that have a high potential to improve tissue characterization in terms of sensitivity and specificity. The investigators hypothesize that advanced QUS providing tumor viscoelasticity assessment, sub-resolution tissue structure characterization and US attenuation in the framework of a machine learning classification model can improve HCC diagnosis compared with standard US.
Early detection through systematic US surveillance translates into curative therapy in a higher proportion of patients and into improvements in survival rates. Thus, there is an urgent need to investigate innovative and cost-effective imaging techniques for improving detection and characterization of HCC. The proposed QUS methods are experimental and will be validated in this proof-of-concept clinical study. A major impact of this work, for patients and medical institutions, will be to improve early-stage detection and characterization of HCC, and offer alternatives in patients with negative or inconclusive conventional US. QUS are low-cost, non-invasive and non-irradiating imaging modalities available from a single exam (i.e., no additional imaging session is necessary).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are at least 18 years old at screening;
Able to comprehend and willingness to provide voluntary consent;
Are able to have a MRI;
Understand French or English;
Disqualifiers
Are pregnant or trying to become pregnant;
Have a weight or girth preventing from entering the MR magnet bore;
Are unable to understand or unwilling to provide written informed consent for this study;
Have a contraindication to MRI (pacemaker, insurmountable claustrophobia);
Trial population
The investigators propose a cross-sectional prospective clinical study with two sequential cohorts: 1) a training cohort of 100 patients at risk for HCC to optimize QUS biomarkers for classification of solid liver lesions using MRI and/or biopsy as gold standard clinical references; and 2) a validation cohort of 100 patients to confirm diagnostic performance. The investigators will recruit patients seen at the hepatology clinic of the University of Montreal Hospital (CHUM).
Trial design
Other
Cross-sectional
Treatments tested in this trial
Magnetic Resonance Viscoelastography
DeviceMagnetic Resonance Viscoelastography
QUS
DeviceQUS
Treatment groups
Trial outcomes
Primary outcomes
Liver viscoelastography determined by MRI
Measure of liver viscoelastography using magnetic resonance Imaging (MRI)
Liver viscoelastography determined by QUS
Measure of liver viscoelastography using quantitative ultrasound (QUS).
Detection of focal HCC lesions
Detection of focal HCC lesions using quantitative ultrasound (QUS).
Sponsors and contacts
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
Siemens Corporation, Corporate Technology
Collaborator
Fonds de la Recherche en Santé du Québec
Collaborator
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Collaborator