An interventional study of AI-assisted abdominal CE-CT reporting and Standard abdominal CE-CT reporting without AI assistance in Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc) and Hepatic Metastasis, sponsored by Shengjing Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Shengjing Hospital · Not applicable, Interventional, and Diagnostic
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.
Multiphasic contrast-enhanced computed tomography (CE-CT) is widely used to evaluate focal liver lesions, but clinically significant malignancies may be missed or incompletely characterized. This prospective, multicenter, pragmatic, cluster-randomized, center-day crossover trial will compare AI-assisted reporting with standard radiology reporting. Center-days will be assigned in an approximately 1:1 ratio using a centrally generated randomized sequence, and each participant will receive only one workflow. In the AI-assisted arm, the radiologist will save an unaided initial assessment before the locked AI output is revealed and may revise or retain the assessment before authorizing the final report. In the control arm, examinations will be interpreted without access to AI outputs. The primary outcome will be the proportion of participants with a reference-standard-confirmed clinically significant malignant focal liver lesion that was missed or inadequately characterized in the final report. The reference standard will incorporate histopathology, follow-up imaging, multidisciplinary consensus, and relevant clinical records. Non-inferiority will be assessed using a margin prespecified in the statistical analysis plan before enrollment, followed by superiority testing if non-inferiority is demonstrated. Secondary outcomes include senior-review workload, final report turnaround time, detection rate of clinically significant malignant liver lesions, clinically appropriate management-change rate, and time to initiation of treatment for liver malignancy.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 40,000 is above the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Shengjing Hospital is the lead sponsor of 127 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Intervention: AI-assisted interpretation of abdominal CE-CT
Other: AI-assisted abdominal CE-CT reporting
Routine interpretation of abdominal CE-CT without access to AI system (standard of care)
Other: Standard abdominal CE-CT reporting without AI assistance
After the unaided initial assessment is saved, the locked AI system will display lesion localization, patient-level and lesion-level malignancy probabilities, prespecified lesion-class suggestions, and uncertainty or technical-failure warnings. The first-line radiologist may revise or retain the initial assessment and must record acceptance, rejection, or uncertainty for clinically important AI suggestions. The senior reviewer may view the initial assessment, AI output, and revision history. AI may not autonomously authorize reports, prescribe management, or communicate diagnoses directly to participants.
Eligible multiphasic abdominal CE-CT examinations will be interpreted and reported according to the site's standard radiology workflow, including routine senior review where applicable. AI system outputs will not be available to radiologists or clinical staff, and no AI-triggered safety-net review will be performed. Routine report addenda, urgent communication, multidisciplinary review, additional imaging, and subsequent clinical management will remain available according to standard clinical practice.
Per-participant rate of missed clinically significant liver malignancy
Proportion of all enrolled participants with at least one reference-standard-confirmed clinically significant liver malignancy, including hepatocellular carcinoma, liver metastasis, or another primary hepatic malignancy, that was not identified or appropriately characterized in the final index CE-CT report. The reference standard will comprise histopathology when available; otherwise, 12-month imaging and clinical follow-up and relevant record linkage, adjudicated by an independent committee masked to allocation. Non-inferiority will be assessed against a margin prespecified before enrollment.
Time frame: From the index CE-CT examination through 12 months
Senior-review workload
Number of examinations requiring senior radiologist review per 100 eligible CE-CT examinations, compared between AI-assisted and standard-reporting center-days.
Time frame: Up to 24 hours after the eligible CE-CT examination becomes available for interpretation
Final report turnaround time
Time in minutes from availability of the complete CE-CT examination for interpretation to authorization of the final clinical report.
Time frame: Up to 24 hours after the complete CE-CT examination becomes available for interpretation
Detection rate of clinically significant malignant liver lesions
Proportion of enrolled participants with a reference-standard-confirmed clinically significant malignant liver lesion identified in the final index CE-CT report. Results will be reported overall and for prespecified subgroups, including confirmed HCC smaller than 2 cm, BCLC stage 0 HCC, and liver metastases stratified by primary tumor site.
Time frame: From the index CE-CT examination through 12 months
Clinically appropriate management-change rate
Proportion of participants with an independently adjudicated change in diagnostic evaluation, referral, biopsy, treatment, or surveillance attributable to the final index CE-CT report, including avoidance of unnecessary downstream work-up.
Time frame: From the index CE-CT examination through 12 months
Time to initiation of treatment for liver malignancy
Time in days from the index CE-CT examination to initiation of first anti-hepatic malignancy treatment (surgery, ablation, transarterial therapy, systemic therapy, or radiotherapy) among participants with reference-standard-confirmed malignant liver lesions. Median time and interquartile range will be reported, and the proportion of participants starting treatment within clinically relevant time thresholds (e.g., 30 days, 60 days, 90 days) will be compared between groups.
Time frame: From the index CE-CT examination through 12 months
Plan to share: Yes
Supporting information: Study protocol
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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