Different Abbreviated MRI for Hepatocellular Carcinoma Diagnosis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06663904

Acronym

AMRI; LIRADS

Enrollment

938

Registered

2024-10-29

Start date

2021-01-01

Completion date

2023-12-31

Last updated

2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma (HCC)

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Number of patients with HCC	immediately after the surgery

Secondary

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

Countries

China

Outcome results