NCT07768085Not yet recruiting
Pragmatic RCT of AI-Assisted Reading for Malignant Hepatic Lesions on CE-CT
A Multicenter Randomized Controlled Trial of AI-Assisted Reading Compared With Standard Radiology Interpretation for Malignant Hepatic Lesions on Contrast-Enhanced CT: Diagnostic, Clinical and Workflow Outcomes
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40000 (estimated)
- First submitted
- 11 Aug 2026
- Start date
- 17 Aug 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Shengjing Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07768085
What you commit to
- Study type: Interventional
- Planned participants: 40000
- From 17 Aug 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of recent upper-abdominal surgery (within 30 days) or major hepatobiliary-pancreatic surgery affecting liver evaluation (e.g., liver transplantation or Whipple procedure); patients with prior simple cholecystectomy or single-lesion interventional procedures are not excluded
Other illness
- History of recent hepatic trauma (within 30 days)
Other
- Poor image quality or severe noise artifacts (e.g., metal or motion artifacts)
- Missing required imaging phases (required at least non-contrast, arterial, and venous phases) or inadequate scan range (e.g., lower-abdomen CT such as pelvic or rectal scans not covering the liver)
Who the study is looking for
- Age range 18 years and above
- Underwent dynamic contrast-enhanced abdominal CT examination with liver coverage
- Imaging must include at least three required phases: non-contrast, arterial phase, and venous phase; a delayed phase is optional
- Complete imaging data that meet AI system and radiologist interpretation requirements.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.