Improving Hepatocellular Carcinoma Screening

NCT ID: NCT05828446

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Magnetic Resonance Imaging Hepatocellular Carcinoma Screening Contrast-enhanced US

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single center interventional prospective study
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

MRI

Intervention Type DEVICE

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

Interventions

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MRI

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

Intervention Type DEVICE

Other Intervention Names

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Constrast-enhanced US

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Naik Vietti Violi

OTHER

Sponsor Role lead

Responsible Party

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Naik Vietti Violi

Radiologist, Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Naik Vietti Violi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

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Lausanne University Hospital

Lausanne, Canton of Vaud, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Naik Vietti Violi, MD

Role: CONTACT

+41213144556

Clarisse Dromain, MD

Role: CONTACT

+41213144556

Facility Contacts

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Naik Vietti Violi, MD

Role: primary

+41795560240

Other Identifiers

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CER-VD 2022-D0116

Identifier Type: -

Identifier Source: org_study_id

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