Early Detection of Liver Cancer by QUS (QUS in HCC)

March 18, 2026 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Quantitative Ultrasound to Improve Detection and Diagnosis of Liver Cancer

Worldwide, liver cancers are the third most common cause of cancer mortality. Even when liver cancer is suspected by blood tests, imaging is required to determine the location, size, and extent of disease. Medical societies therefore recommend surveillance with ultrasound every 6 months in at-risk patients. However, a key challenge to improving the survival is that ultrasound may miss half of early-stage liver cancers, thus diagnosis must rely on additional tests such as computed tomography (CT), magnetic resonance imaging (MRI), or biopsy. Hence, there is a clear need to improve the ability to detect liver cancers, especially with ultrasound. The investigator's team proposes novel ultrasound approaches to detect cancer nodules invisible on conventional ultrasound based on differences in mechanical and structural properties between liver and tumor. Improving detection is critical because liver cancer can be cured only if detected at an early stage, as shown by improvements in survival rates in patients enrolled in surveillance programs. The investigator's multi-disciplinary, national, and international team includes experts in clinical fields (hepatology, oncology, radiology, pathology), basic sciences (engineering, medical physics, machine learning, biostatistics), and patient partnership. The investirgator will apply the methodology of patient partner recruitment and collaborate with the Centre of Excellence on Partnership with Patients and the Public to select potential new collaborators. This will permit this project to be informed at every stage by patient and family perspectives, ensuring that the results of this project will be more robust, impactful, and aligned with the priorities, needs and experiences of those who live with liver cancer. The investigator submits a research proposal focused on advanced imaging techniques because imaging constitutes a foundation for surveillance, diagnosis, staging, treatment selection and assessment of treatment response in patients with liver cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND Worldwide, liver cancers are the third most common cause of cancer mortality. In Canada, hepatocellular carcinoma (HCC) is one of the few cancers for which mortality is increasing. Early detection of HCC improves the likelihood of curative treatment and survival. Systematic HCC surveillance with ultrasound (US) is recommended by practice guidelines. However, conventional (B-mode) US suffers from low sensitivity (47%) for detecting early-stage HCC due to fatty liver, obesity, and cirrhosis. Once a suspicious nodule is detected by US, guidelines recommend contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) to confirm cancer. Hence, there is an urgent need to improve the ability to detect and diagnose HCC early. Members of the investigator's team have developed innovative quantitative ultrasound (QUS) techniques (including shear wave viscoelastography [SWV] and sub-resolution cellular imaging) that have a high diagnostic potential. The investirgator hypothesizes that a combination of QUS techniques offering complementary assessment of tissue characteristics will improve our ability to detect liver nodules and diagnose HCC.

METHODOLOGY Design: Prospective, cross-sectional imaging trial comparing head-to-head B-mode US and research QUS acquired within one month to the composite reference standard. Reference standard: MRI will be used as the non-invasive ground truth for liver nodules detection and classification except when biopsy is available. Data analysis: Lesion detectability will be measured by contrast-to-noise ratio on US and QUS maps for different size thresholds (<10 mm, 10-20 mm, >20 mm) used in diagnostic algorithms. Diagnostic performance will be measured by receiver operating characteristic curve analysis on the training and test sets for different size thresholds. The diagnostic accuracy of US and QUS + B-mode US will be compared by using the DeLong method.

RATIONALE AND IMPACT Early detection through systematic US surveillance translates into curative therapy in a higher proportion of patients and into improvements in survival rates. This imaging trial will provide a low-cost imaging technique to identify liver cancers earlier and from a single exam. Unlike some other imaging techniques, US is widely available throughout Canada. A major impact of this work, for patients and medical institutions, will be to lower the need for liver biopsy, the risk of complications and the cost for HCC diagnosis. This trial will position Canada as a leader in HCC diagnosis as new QUS and SWV biomarkers will be tested.

Study Type

Observational

Enrollment (Estimated)

328

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for US- or MRI-based surveillance of HCC or undergoing MRI-based imaging for characterization of liver nodules as part of their clinical standard of care.

Description

Inclusion Criteria:

- Adult patients scheduled for US- or MRI-based surveillance of HCC or undergoing MRI-based imaging for characterization of liver nodules as part of their clinical standard of care.

Exclusion Criteria:

- Patients with prior locoregional or systemic therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the sensitivity of QUS + B-mode US vs B-mode US alone for lesion detection, using MRI as the reference standard for detection
Time Frame: Within one month of the composite reference test (conventional MRI or pathology).
Lesion detectability will be measured by contrast-to-noise ratio on US and QUS maps for different size thresholds (<10 mm, 10-20 mm, >20 mm) used in diagnostic algorithms
Within one month of the composite reference test (conventional MRI or pathology).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the specificity of QUS + B-mode US vs B-mode US alone for diagnosis of HCC, using MRI or biopsy as the composite reference standard for classification
Time Frame: Within one month of the composite reference test (conventional MRI or pathology).
Diagnostic performance will be measured by receiver operating characteristic curve analysis on the training and test sets for different size thresholds
Within one month of the composite reference test (conventional MRI or pathology).
Determine the lesion-to-liver contrast of investigational QUS techniques for detection of HCC
Time Frame: Within one month of the composite reference test (conventional MRI or pathology).
The diagnostic accuracy of US and QUS + B-mode US will be compared by using the DeLong method
Within one month of the composite reference test (conventional MRI or pathology).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Canadian Institutes of Health Research (CIHR)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2024

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-12161

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on Quantitative Ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe