Recruiting

Liver Cancer

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06345508

Conditions

Hepatocellular Carcinoma

Liver Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quantitative Ultrasound

B-mode Ultrasound

Magnetic Resonance Imaging

Liver Biopsy

Study Details

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

Study ID

NCT06345508

Start date

Aug 20, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

328 participants

Anticipated

Interventions and Outcome Measures

Interventions

Quantitative Ultrasound

Research quantitative ultrasound

B-mode Ultrasound

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

Magnetic Resonance Imaging

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

Liver Biopsy

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

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). ]

Central Contacts and Locations

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Principal Investigator:

An Tang, MD, MSc

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-03-20.