Improving Hepatocellular Carcinoma Screening

Hepatocellular Carcinoma Clinical Trial

— AMRIK  

Official title:

Prospective Comparison of Diagnostic Performance and Cost-effectiveness of US and Abbreviated MRI for Hepatocellular Carcinoma Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05828446
• Other study ID #: CER-VD 2022-D0116
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 30, 2027

Study information

• Verified date: May 2023
• Source: University of Lausanne Hospitals
• Contact: Naik Vietti Violi, MD
• Phone: +41213144556
• Email: naik.vietti-violi[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Magnetic Resonance Imaging
• Screening

Intervention

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

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Naik Vietti Violi

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare the patient-level accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of US +/- CEUS vs. AMRI for HCC.	Diagnostic performance of the different tests [(1)US alone, (2) US + CEUS, (3) NC-AMRI, (4) Dyn-AMRI] will be compared using all patient information (including complete MRI and pathology) as the reference standard.; Outcome measures will be compared in terms accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)	Through study completion, an average of 1 year.
Secondary	Evaluate patient satisfaction and comfort with US +/- CEUS vs. AMRI with a questionnaire	In order to evaluation patient's opinion a survey regarding patient experience and opinion to the different test will be performed.; Outcome will be measured in term of level of confort using a 5-scale score: from low discomfort to high discomfort: No discomfort; Low discomfort; Neutral; Comfort; high comfort	Once, after the first screening round (US+/-CEUS and MRI), 6 months
Secondary	To develop and test a DL model for HCC detection based on AMRI.	AMRI DL based model will be analysed in terms of (1) diagnostic performance (ROC, AUC, sensitivitiy, specificity, accuracy) and (2) time savings compared to AMRI read by a radiologist.	Through study completion, an average of 1 year.
Secondary	To perform a cost-effectiveness analysis comparing US to different alternative screening strategies for HCC in Switzerland.	Cost effectiveness analysis will be perfomed by building a model using all study data: patient characteristics, exam diagnostic performance and patient management costs.; Outcome will be analysed in terms of Lifetime costs, quality adjusted life expectancy	Through study completion, an average of 1 year.
Secondary	To perform a cost-effectiveness analysis comparing US to different alternative screening strategies for HCC in Switzerland.	Cost effectiveness analysis will be perfomed by building a model using all study data: patient characteristics, exam diagnostic performance and patient management costs.; Outcome will be analysed in terms of incremental costs effectiveness ratios.	Through study completion, an average of 1 year.