Improving Hepatocellular Carcinoma Screening

NCT05828446 | Recruiting DMC

• 1 other identifier: CER-VD 2022-D0116
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnetic Resonance Imaging; Hepatocellular Carcinoma; Screening; Contrast-enhanced US

Outcome Measures

Primary Outcomes (1)

• To compare the diagnostic performance of US+/- CEUS and AMRI for HCC detection in an at-risk population

  The patients will undergo all the normal follow-up according to clinical recommendations, consisting of a bi-annual clinical visit in the gastro-enterology department and an US. The US will be followed by CEUS in case of suspicious lesion. On the same week, the study participants will undertake MRI. The data of the full MRI will be used to reconstruct two different AMRI sets for reading: non-contrast (NC-) and dynamic (Dyn-) AMRI. The endpoint is the rate of HCC detection. Outcome measures will be compared in terms of ROC curve and AUC.

  Through study completion, an average of 1 year.

Secondary Outcomes (5)

• Compare the patient-level accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of US +/- CEUS vs. AMRI for HCC.

  Through study completion, an average of 1 year.

• Evaluate patient satisfaction and comfort with US +/- CEUS vs. AMRI with a questionnaire

  Once, after the first screening round (US+/-CEUS and MRI), 6 months

• To develop and test a DL model for HCC detection based on AMRI.

  Through study completion, an average of 1 year.

• To perform a cost-effectiveness analysis comparing US to different alternative screening strategies for HCC in Switzerland.

  Through study completion, an average of 1 year.

• To perform a cost-effectiveness analysis comparing US to different alternative screening strategies for HCC in Switzerland.

  Through study completion, an average of 1 year.

Study Arms (1)

HCC screening population according to European Association for the Study of the Liver recommendation

EXPERIMENTAL

Device: MRI

Interventions

MRI DEVICE

To compare the diagnostic performance of US+/- Constrast-enhanced US and AMRI for HCC detection in an at-risk population

Also known as: Constrast-enhanced US

HCC screening population according to European Association for the Study of the Liver recommendation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Naik Vietti Violi: lead

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Naik Vietti Violi, MD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naik Vietti Violi, MD

CONTACT

+41213144556; naik.vietti-violi@chuv.ch

Clarisse Dromain, MD

CONTACT

+41213144556; Clarisse.dromain@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Radiologist, Principal investigator

Model Details: single center interventional prospective study

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: April 25, 2023
• Study Start: April 1, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

CH (1)