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Viscoelasticity Imaging to Assess Liver Cancer

NCT04409340 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-10-02

No results posted yet for this study

Summary

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).

Conditions

Interventions

DEVICE

Magnetic Resonance Viscoelastography

Magnetic Resonance Viscoelastography

DEVICE

QUS

QUS

Sponsors & Collaborators

  • Siemens Corporation, Corporate Technology

    collaborator INDUSTRY

  • Fonds de la Recherche en Santé du Québec

    collaborator OTHER_GOV

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Guy Cloutier, PhD · Centre hospitalier de l'Université de Montréal (CHUM)

  • An Tang, MD, MSc · Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2023-10-31
Completion
2023-12-22

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04409340 on ClinicalTrials.gov