Clinical trial NCT05828446: Improving Hepatocellular Carcinoma Screening
Official title: Prospective Comparison of Diagnostic Performance and Cost-effectiveness of US and Abbreviated MRI for Hepatocellular Carcinoma Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Magnetic Resonance Imaging
Hepatocellular Carcinoma
Screening
Contrast-enhanced US
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single center interventional prospective study
Primary purpose: SCREENING

Brief summary: This is a monocentric, single blind, interventional, single arm study. It is designed to compare the rates of detection of hepatocellular carcinoma (HCC) by ultrasound (US) used in clinical routine vs. abbreviated magnetic resonance imaging (AMRI). The hypothesis is that dynamic AMRI with extracellular contrast agent injection has a higher patient-level detection rate of HCC than screening US and non-contrast AMRI.

Interested and eligible patients will be enrolled and undergo HCC screening rounds including US +/- contrast-enhanced US (clinical routine) and screening MRI within the same week bi-annually.


Eligibility criteria: Inclusion Criteria:

* All adult patients with chronic liver disease and indication for HCC screening according to the European Association for the Study of the Liver recommendations.
* Informed Consent signed by the subject

Exclusion Criteria:

* History of HCC
* History of other malignancy
* Prior liver nodule categorized as LI-RAD 4, 5 or M
* History of liver transplantation
* Pregnancy
* MRI or MRI contrast agent precaution
* Any other condition making the patient unsuitable for the study
* Patient's refusal of transmission of relevant medical conditions found on the medical examinations performed during the study

Primary outcomes:
measure: To compare the diagnostic performance of US+/- CEUS and AMRI for HCC detection in an at-risk population
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Compare the patient-level accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of US +/- CEUS vs. AMRI for HCC.
timeFrame: Through study completion, an average of 1 year.
measure: Evaluate patient satisfaction and comfort with US +/- CEUS vs. AMRI with a questionnaire
timeFrame: Once, after the first screening round (US+/-CEUS and MRI), 6 months
measure: To develop and test a DL model for HCC detection based on AMRI.
timeFrame: Through study completion, an average of 1 year.
measure: To perform a cost-effectiveness analysis comparing US to different alternative screening strategies for HCC in Switzerland.
timeFrame: Through study completion, an average of 1 year.
measure: To perform a cost-effectiveness analysis comparing US to different alternative screening strategies for HCC in Switzerland.
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: Naik Vietti Violi, MD
role: PRINCIPAL_INVESTIGATOR
References: