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

Sun Yat-sen University

Status: Completed

Conditions: Hepatocellular Carcinoma (HCC)

Study type: Observational

Funder types: Other

Identifiers

NCT06663904

SYSUFAH2021124

2024A1515012149, 2023A15150110 (Other Grant/Funding Number)

82271958 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 938 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

938 participants in 2 patient groups

HCC group

Description:

No previous treatments were performed before MRI examination of patients.

Non-HCC group

Description:

No previous treatments were performed before MRI examination of patients.