Viscoelasticity Imaging to Assess Liver Cancer

NCT04409340 | Unknown

• 1 other identifier: 2021-8561
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Liver viscoelastography determined by MRI

  Measure of liver viscoelastography using magnetic resonance Imaging (MRI)

  Within 6 weeks of liver echography

• Liver viscoelastography determined by QUS

  Measure of liver viscoelastography using quantitative ultrasound (QUS).

  Within 6 weeks of liver echography

• Detection of focal HCC lesions

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

  Within 6 weeks of liver echography

Study Arms (2)

Training cohort

All patients enrolled will undergo: * Magnetic Resonance Viscoelastography * Quantitative ultrasound (QUS)

Device: Magnetic Resonance Viscoelastography; Device: QUS

Validation cohort

All patients enrolled will undergo: • Quantitative ultrasound (QUS)

Device: QUS

Interventions

Magnetic Resonance Viscoelastography DEVICE

Magnetic Resonance Viscoelastography

Training cohort

QUS DEVICE

QUS

Training cohort; Validation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Guy Cloutier, PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

• An Tang, MD, MSc

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Cloutier, PhD

CONTACT

514-890-8000; guy.cloutier@umontreal.ca

Louise Allard, PhD

CONTACT

514-890-8000; louise.allard@crchum.qc.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: October 5, 2020
• Primary Completion: October 31, 2023
• Study Completion: December 22, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

CA (1)