NCT04409340Recruiting
Viscoelasticity Imaging to Assess Liver Cancer
Added Value of Shear Wave Viscoelasticity Imaging, Homodyned-K Tissue Imaging and Acoustic Attenuation to Assess Liver Cancer at Ultrasound: a Multiparametric Learning Approach
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 27 May 2020
- Start date
- 5 Oct 2020
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04409340
What you commit to
- Study type: Observational
- Planned participants: 200
- From 5 Oct 2020 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have chronic kidney disease preventing the injection of gadolinium-based contrast agent.
Other
- 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);
Who the study is looking for
- 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;
- Patients enrolled in a monitoring program or referred for the characterization of a focal liver lesion;
- Focal liver lesion is visible during ultrasound screening in B-mode.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.