Early Detection of Liver Cancer by QUS

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • Quantitative Ultrasound

    Diagnostic test

    Research quantitative ultrasound

  • B-mode Ultrasound

    Diagnostic test

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

  • Magnetic Resonance Imaging

    Diagnostic test

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

  • Liver Biopsy

    Diagnostic test

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

Treatment groups

No treatment groups listed

Trial outcomes

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

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

Secondary outcomes

1

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

Diagnostic performance will be measured by receiver operating characteristic curve analysis on the training and test sets for different size thresholds

Time frame
Within one month of the composite reference test (conventional MRI or pathology).
2

Determine the lesion-to-liver contrast of investigational QUS techniques for detection of HCC

The diagnostic accuracy of US and QUS + B-mode US will be compared by using the DeLong method

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

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

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator