Focal Liver Lesions
Conditions
Interventions
Gold Standard:Malignant FLLs require pathological confirmation, while benign FLLs require a 3-month follow-up.
Index test:Artificial Intelligence (AI) Diagnostic Imaging System for Liver Diseases
Sponsors
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. Presence of a hepatic space-occupying lesion (or liver mass) detected by ultrasound examination or screening computed tomography (CT). 3. Underwent a baseline contrast-enhanced CT (CECT) scan of the liver. 4. Underwent hepatic Dynamic Contrast-Enhanced MRI (DCE-MRI) and EOB-MRI scans within 15 days of the baseline CT. The MR system must have a field strength of at least 1.5 Tesla (T), with a slice thickness of <= 5 mm for T1-weighted sequences and <= 8 mm for T2-weighted sequences. 5. Availability of an accurate and reliable gold standard for the liver lesion, defined as either histopathological examination within 30 days of the baseline MRI or imaging follow-up for at least 3 months.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from this study if they meet any of the following criteria: 1. Prior treatment specifically targeting the focal liver lesion(s). 2. Poor quality of liver CT or MRI images, such as those with severe motion artifacts that preclude lesion assessment. 3. Inconclusive or indeterminate diagnosis of the focal liver lesion(s) based on histopathological examination or post-baseline imaging follow-up. 4. Patients with inflammatory liver lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Positive predictive value;Negative predictive value;Time;Accuracy rate;Miss rates;Misdiagnosis rate;Detection rates; | — |
Countries
China
Contacts
Public ContactFuhua Yan
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed