Different Abbreviated MRI for Hepatocellular Carcinoma Diagnosis (AMRI; LIRADS)

October 28, 2024 updated by: Yanjin Qin, First Affiliated Hospital, Sun Yat-Sen University

Multicenter Validation of Different Abbreviated MRI Protocols for Early-Stage Hepatocellular Carcinoma Diagnosis Using Main and Ancillary Features of LI-RADS

Abbreviated MRI (AMRI) could improve the diagnostic performance of hepatocellular carcinoma (HCC), but it lacks analysis in different subgroups and effective validation. The investigators aimed to compare and validate the diagnostic performance of different AMRI protocols in diagnosing early-stage HCC.

Study Overview

Status

Completed

Conditions

Hepatocellular Carcinoma (HCC)

Detailed Description

This retrospective study enrolled untreated patients at risk for developing HCC who underwent gadoxetic acid-enhanced MRI from three independent cohorts from January 2020 to December 2022. Three AMRI protocols were extracted from the complete liver MRI protocol, including non-contrast (NC-AMRI), hepatobiliary phase (HBP-AMRI); and dynamic contrast-enhanced (DCE-AMRI). Two readers at each cohort independently interpreted each AMRI based on ancillary and main features from the Liver Imaging Reporting and Data System (LI-RADS) version 2018. For DCE-AMRI, two established algorithms were employed: modified LI-RADS (DCE-AMRIm) and LI-RADS v2018 (DCE-AMRIv2018). Non-HCCs were ascertained based on histologic and clinical follow-up data, while early-stage HCCs were confirmed post-operatively. Patient-level performance metrics were compared using bootstrap resampling and generalized estimating equations.

Study Type

Observational

Enrollment (Actual)

938

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Guangdong
  - Guangzhou, Guangdong, China, 510000
    - China, Guangdong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Consecutive participants at risk for developing HCC (ie, liver cirrhosis of any etiologies or chronic hepatitis virus infections) who underwent gadoxetic acid-enhanced MRI between January 2020 and December 2022 and are eligible for inclusion in this study.

Description

Inclusion Criteria:

no previous history of HCC treatment
no history of any other underlying malignancy besides HCC.

Exclusion Criteria:

For HCC group: (a) without preoperative MRI within 3 months; (b) without postoperative pathological confirmation; (c) liver cirrhosis without histopathologic proof or radiologic evidence; (d) the size of HCC smaller than 1cm; (e) outside of Milan Criteria; and (f) suboptimal imaging quality.
For non-HCC group: 1) lost follow-up, 2) insufficient follow-up period, or 3) suboptimal imaging quality.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
HCC group No previous treatments were performed before MRI examination of patients.
Non-HCC group No previous treatments were performed before MRI examination of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with HCC Time Frame: immediately after the surgery	immediately after the surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with non-HCC Time Frame: immediately after pathology from postoperative or biopsy samples, or clinical diagnosis after at least 1 year without imaging indications of liver malignancy.	immediately after pathology from postoperative or biopsy samples, or clinical diagnosis after at least 1 year without imaging indications of liver malignancy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

October 26, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)