Hepatocellular CarcinomaQUS in HCCNCT06345508
Early Detection of Liver Cancer by QUS
An observational study of Hepatocellular Carcinoma and Liver Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer
- What is being tested?
- Quantitative Ultrasound, B-mode Ultrasound and Magnetic Resonance Imaging
- How many people
- 328 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2024to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with prior locoregional or systemic therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0A9
An Tang, MD, MSc, 514-890-8000 ext. 36400, an.tang@umontreal.ca
Casey Bourdeau Caporuscio, MSc, 514-890-8000 ext. 14756, casey.bourdeau-caporuscio.chum@ssss.gouv.qc.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Being tested
- Quantitative Ultrasound, B-mode Ultrasound, Magnetic Resonance Imaging, Liver Biopsy
- Keywords
- Ultrasound, Quantitative ultrasound (QUS), Liver cancer, Hepatocellular carcinoma, Elastography, Viscoelastography, Screening, Surveillance, Diagnosis, Diagnostic performance
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative UltrasoundDiagnostic test
Also called QUS
Research quantitative ultrasound
B-mode UltrasoundDiagnostic test
Also called B-mode US
B-mode US performed according to the clinical standard of care.
Magnetic Resonance ImagingDiagnostic test
Also called MRI
The composite reference standard includes MRI performed according to the clinical standard of care or histopathology when available.
Liver BiopsyDiagnostic test
The composite reference standard includes MRI performed according to the clinical standard of care or histopathology when available.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Diagnostic performance will be measured by receiver operating characteristic curve analysis on the training and test sets for different size thresholds
Measured: 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
The diagnostic accuracy of US and QUS + B-mode US will be compared by using the DeLong method
Measured: Within one month of the composite reference test (conventional MRI or pathology).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start20 Aug 2024
- Primary completionJun 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345508
- Sponsor's protocol ID
- 2024-12161
- Acronym
- QUS in HCC
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Ultrasound to Improve Detection and Diagnosis of Liver Cancer
- ClinicalTrials.gov ID
- NCT06345508
- Acronym / sponsor ID
- QUS in HCC / 2024-12161
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Keywords
- Ultrasound, Quantitative ultrasound (QUS), Liver cancer, Hepatocellular carcinoma, Elastography, Viscoelastography, Screening, Surveillance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Canadian Institutes of Health Research (CIHR)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with prior locoregional or systemic therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative UltrasoundAlso: QUSResearch quantitative ultrasound | Diagnostic test | – |
| B-mode UltrasoundAlso: B-mode USB-mode US performed according to the clinical standard of care. | Diagnostic test | – |
| Magnetic Resonance ImagingAlso: MRIThe composite reference standard includes MRI performed according to the clinical standard of care or histopathology when available. | Diagnostic test | – |
| Liver BiopsyThe composite reference standard includes MRI performed according to the clinical standard of care or histopathology when available. | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.