本研究旨在以随机方式,在接受三相对比CT的风险人群中,前瞻性验证此AI演算法,并与现行放射学报告标准进行比较。本研究项目完全独立,与当值放射科医生实际的CT扫描临床报告分开。
适应症:Hepatocellular Carcinoma
入组条件
纳入标准
- \. Age \>=18 years.
- \. Defined as the at-risk population requiring regular liver ultrasonography surveillance.
- These include:
- Cirrhotic patients of any disease etiology,
- Chronic hepatitis B patients of age ≥40 years for men, age ≥50 years for women or with a family history of HCC.
- \. At least one new-onset focal liver nodule detected on liver ultrasonography.
排除标准
- \. Liver nodules of \<1 cm. Currently such nodules are not reported using LI-RADS criteria but are recommended for a repeat scan in 3-6 months. In patients with multiple liver nodules, the largest nodule will be assessed.
- \. Patients with contraindications for contrast CT imaging, including a history of contrast anaphylaxis and impaired renal function (glomerular filtration rate \<30 ml/min).
- \. Patients with prior transarterial chemoembolization or other interventional procedures with intrahepatic injection of lipiodol. Lipiodol is extremely hyperdense on computed tomography and will preclude objective interpretation. Such patients were also excluded in the development of our prototype AI algorithm.
入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。