Early Detection of Liver Cancer by QUS

NCT06345508 | Recruiting

• 1 other identifier: 2024-12161
• Study Type: observational
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; Liver Cancer

Keywords

Ultrasound; Quantitative ultrasound (QUS); Liver cancer; Hepatocellular carcinoma; Elastography; Viscoelastography; Screening; Surveillance; Diagnosis; Diagnostic performance

Outcome Measures

Primary Outcomes (1)

• Compare the sensitivity of QUS + B-mode US vs B-mode US alone for lesion detection, using MRI as the reference standard for detection

  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 Outcomes (2)

• 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

  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

  Within one month of the composite reference test (conventional MRI or pathology).

Interventions

B-mode Ultrasound DIAGNOSTIC_TEST

B-mode US performed according to the clinical standard of care.

Also known as: B-mode US

Magnetic Resonance Imaging DIAGNOSTIC_TEST

The composite reference standard includes MRI performed according to the clinical standard of care or histopathology when available.

Also known as: MRI

Liver Biopsy DIAGNOSTIC_TEST

The composite reference standard includes MRI performed according to the clinical standard of care or histopathology when available.

Quantitative Ultrasound DIAGNOSTIC_TEST

Research quantitative ultrasound

Also known as: QUS

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

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.

You may qualify if:

• \- 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.

You may not qualify if:

• \- Patients with prior locoregional or systemic therapy.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): lead
• 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

Carcinoma, Hepatocellular; Liver Neoplasms; Disease

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

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

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CA (1)