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Research on Risk Assessment of Malignant Transformation for Non-hypervascular Hepatobiliary-phase Hypointense Nodules in the Liver Based on EOB-MRI

Research on Risk Assessment of Malignant Transformation for Non-hypervascular Hepatobiliary-phase Hypointense Nodules in the Liver Based on EOB-MRI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114857
Enrollment
Unknown
Registered
2025-12-18
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Hepatocellular Carcinoma

Interventions

Training and validation sets:None
Test group:None

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with Hepatitis B-related Liver Cirrhosis and Intrahepatic NHHNs: (1) Hepatitis B virus-related liver cirrhosis; (2) Newly detected intrahepatic NHHNs (<= 3 nodules) identified by EOB-MRI; (3) No history of treatment for HCC; (4) No history of other malignancies. 2. Patients with New Intrahepatic NHHNs after Achieving at Least 6 Months of Complete Response Following Local Therapy for Hepatitis B-related HCC: (1) Hepatitis B virus-related hepatocellular carcinoma (clinically or pathologically diagnosed), BCLC stage 0-B; (2) Having undergone local therapy (e.g., TACE, RFA, MWA); (3) Achieved complete response in the treated lesions for at least 6 months (according to mRECIST criteria); (4) Newly detected intrahepatic NHHNs (<= 3 nodules) identified by EOB-MRI; (5) No history of other malignancies.

Exclusion criteria

Exclusion criteria: 1. Patients with Hepatitis B-related Liver Cirrhosis and Intrahepatic NHHNs: (1) Contraindications to EOB-MRI scanning; (2) Patients with a confirmed diagnosis of hepatocellular carcinoma (HCC); (3) Poor image quality or incomplete MRI sequences; (4) Patient death or loss to follow-up. 2. Patients with New Intrahepatic NHHNs after Achieving at Least 6 Months of Complete Response Following Local Therapy for Hepatitis B-related HCC: (1) Receipt of systemic anti-tumor therapy (e.g., targeted drugs, immunotherapy); (2) Contraindications to EOB-MRI scanning; (3) Poor image quality or incomplete MRI sequences; (4) Patient death or loss to follow-up.

Design outcomes

Primary

MeasureTime frame
Malignant Transformation Rate;Sensitivity;Specificity;Accuracy;Area Under the Receiver Operating Characteristic Curve;

Countries

China

Contacts

Public ContactPeng Huang

The Affiliated Hospital of Qingdao University

chaffee_hp@163.com+86 156 1588 6988

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026