Viscoelasticity Imaging to Assess Liver Cancer

ConditionLiver Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Magnetic Resonance Viscoelastography

    Device

    Magnetic Resonance Viscoelastography

  • QUS

    Device

    QUS

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Training cohort2 interventions
Group B: Validation cohort1 intervention

Trial outcomes

Primary outcomes

1

Liver viscoelastography determined by MRI

Measure of liver viscoelastography using magnetic resonance Imaging (MRI)

Time frame
Within 6 weeks of liver echography
2

Liver viscoelastography determined by QUS

Measure of liver viscoelastography using quantitative ultrasound (QUS).

Time frame
Within 6 weeks of liver echography
3

Detection of focal HCC lesions

Detection of focal HCC lesions using quantitative ultrasound (QUS).

Time frame
Within 6 weeks of liver echography

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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