Cyst

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Condition / disease
Location
Status: Not yet recruiting

Pragmatic RCT of AI-Assisted Reading for Malignant Hepatic Lesions on CE-CT

The purpose of this multicenter pragmatic randomized controlled trial is to determine whether AI-assisted interpretation of multiphasic liver contrast-enhanced computed tomography (CE-CT) is non-inferior to standard radiology reporting with respect to missed clinically significant malignant focal liver lesions, \*\*with the non-inferiority margin prespecified in the statistical analysis plan before enrollment\*\*, and whether it improves lesion detection, diagnostic characterization, downstream clinical management, and reporting efficiency. On AI-assisted center-days, AI results will be revealed only after the first-line radiologist has saved an unaided initial assessment and may be used to revise the final report. On control center-days, examinations will be interpreted using the standard radiology workflow without access to AI tools.

Participants needed: 40,000
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Shengjing HospitalUpdated: Aug 17, 2026Locations: 1
Eligibility criteria

Age range 18 years and above [+3]

History of recent upper-abdominal surgery (within 30 days) or major hepatobiliar... [+3]