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Diagnosis and Differential Diagnosis of Focal Liver Lesions Based on Multimodal Imaging, Clinical Characteristics, Biological Behavior and Genomic Features: A Retrospective Study and Prospective Validation

Diagnosis and Differential Diagnosis of Focal Liver Lesions Based on Multimodal Imaging, Clinical Characteristics, Biological Behavior and Genomic Features: A Retrospective Study and Prospective Validation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600131346
Enrollment
Unknown
Registered
2026-09-01
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-09-07

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

Conditions

Hepatic space-occupying lesions encompass a spectrum of benign and malignant diseases, including HCC, ICC, cHCC-CCA, liver metastases, hemangiomas, FNH, HCA, inflammatory and infectious lesions

Interventions

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years, any gender; 2. Diagnosed with hepatic space-occupying lesions through pathology, a combination of clinical and imaging evaluation, multidisciplinary discussion, or standard follow-up, including HCC, ICC, cHCC-CCA, liver metastases, hemangioma, FNH, HCA, cysts, focal fatty changes, liver abscess, inflammatory pseudotumor, regenerative nodules, or atypical hyperplastic nodules, etc.; 3. Has undergone at least one liver-related imaging examination (CT, MRI, ultrasound, contrast-enhanced ultrasound, PET/CT, etc.) at our hospital, and the imaging data quality is sufficient for diagnosis, treatment evaluation, differential diagnosis, or feature extraction; 4. Has available baseline clinical data, lab results, imaging data, treatment information, pathology reports, biological behavior information, any genetic/molecular test results obtained during routine care (if available), or follow-up data; 5. Retrospective cohorts must have traceable medical records or follow-up information; prospective cohorts require informed consent from the patient or legal representative and willingness to follow routine follow-up procedures; 6. For patients with multiple visits or multiple imaging exams, the inclusion time point will be determined by a predefined index date and study purpose to avoid bias from duplicate entries.

Exclusion criteria

Exclusion criteria: 1. Patients with unconfirmed final diagnosis or lesions not belonging to the predefined diagnostic categories of focal liver lesions. 2. Patients complicated with other active primary malignant tumors where the origin of hepatic lesions, diagnostic category or primary study endpoints cannot be clearly identified. 3. Severe missing of key clinical, imaging, pathological or follow-up data that prevents the determination of primary study endpoints or core covariates. Isolated missing genetic/molecular test results shall not serve as an exclusion criterion, yet such cases will be excluded from analyses involving genetic features. 4. Imaging data failing to meet analytical quality requirements, such as severe motion artifacts, incomplete scan coverage, missing key sequences, or unlocalizable lesions. 5. Patients in the prospective cohort who decline study participation or withdraw informed consent, or cases where the investigator judges continued enrollment may compromise the subjects’ rights and interests or the quality of research data.

Design outcomes

Secondary

MeasureTime frame
Sensitivity;Specificity;Area Under the Receiver Operating Characteristic Curve;—

Countries

China

Contacts

Public ContactLiu Liheng

Zhongshan Hospital, Fudan University

henryleozs@126.com+86 21 6404 1990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026