Different Abbreviated MRI for Hepatocellular Carcinoma Diagnosis

NCT06663904 | Completed

• 3 other identifiers: SYSUFAH2021124822719582024A1515012149, 2023A15150110
• Study Type: observational
• Target: 938
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• Number of patients with HCC

  immediately after the surgery

Secondary Outcomes (1)

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

China, Guangdong

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• 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.

  PMID: 41042775 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor tissue specimens reveal distinct morphological features of HCC, such as abnormal cell proliferation, altered cellular architecture, and the presence of cancer nests or trabeculae. Pathologists examine these features to confirm the diagnosis, assess the tumor grade and stage, and identify any surrounding normal or precancerous liver tissue.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical doctor

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: October 29, 2024
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)