Different Abbreviated MRI for Hepatocellular Carcinoma Diagnosis

NCT ID: NCT06663904

Last Updated: 2024-10-29

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

COMPLETED

Total Enrollment

938 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma (HCC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HCC group

No previous treatments were performed before MRI examination of patients.

No interventions assigned to this group

Non-HCC group

No previous treatments were performed before MRI examination of patients.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Yanjin Qin

clinical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China, Guangdong

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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Qin Y, Zhang J, Xu D, Zhou X, Ling Z, Li L, Zhao Q, Dong Z, Wang J, Cai HS, Li H, Zhang LG, Feng ST. Diagnosis of Hepatocellular Carcinoma Using Gadoxetic Acid-Enhanced MRI Based on LI-RADS Version 2018 and LI-RADS Modifications. Liver Int. 2025 Nov;45(11):e70366. doi: 10.1111/liv.70366.

Reference Type DERIVED
PMID: 41042775 (View on PubMed)

Other Identifiers

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82271958

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024A1515012149, 2023A15150110

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SYSUFAH2021124

Identifier Type: -

Identifier Source: org_study_id

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