Recruiting

Liver Cancer

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04409340

Conditions

Liver Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnetic Resonance Viscoelastography

QUS

Study Details

Brief 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

Liver Cancer

Study ID

NCT04409340

Start date

Oct 5, 2020

Status verified date

Sep, 2023

Completion date

Dec 22, 2023

Anticipated

Primary completion date

Oct 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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);
  • Have chronic kidney disease preventing the injection of gadolinium-based contrast agent.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Training cohort

All patients enrolled will undergo:

  • Magnetic Resonance Viscoelastography
  • Quantitative ultrasound (QUS)

Validation cohort

All patients enrolled will undergo:

• Quantitative ultrasound (QUS)

Interventions

Magnetic Resonance Viscoelastography

Magnetic Resonance Viscoelastography

QUS

QUS

Primary outcome measure

  • Liver viscoelastography determined by MRI [ Time Frame: Within 6 weeks of liver echography ]
  • Liver viscoelastography determined by QUS [ Time Frame: Within 6 weeks of liver echography ]
  • Detection of focal HCC lesions [ Time Frame: Within 6 weeks of liver echography ]

Central Contacts and Locations

Locations

Centre hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montréal, Quebec, Canada, H2X 0A9

Contacts

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Oct 2, 2023

Last verified

Sep, 2023

Keywords

  • quantitative ultrasound
  • Viscoelasticity
  • Homodyned-K imaging
  • Liver cancer
  • Viscoelastography
  • Ultrasound attenuation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2023-10-02.