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QUS in HCC
Quantitative Ultrasound to Improve Detection and Diagnosis of Liver Cancer
Sponsor study identifier
observational
328
1 country
1
Study Start
August 20, 2024
Actual (reported)Primary Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 28, 2024
Actual (reported)April 3, 2024
Actual (reported)August 20, 2024
Actual (reported)June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
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
Research quantitative ultrasound
B-mode US performed according to the clinical standard of care.
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.
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0A9, Canada
First Submitted
March 28, 2024
First Posted
April 3, 2024
Study Start
August 20, 2024
Actual (reported)Primary Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Within one month of the composite reference test (conventional MRI or pathology).
The composite reference standard includes MRI performed according to the clinical standard of care or histopathology when available.
The composite reference standard includes MRI performed according to the clinical standard of care or histopathology when available.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
December 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 20, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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