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

N/ANot Yet RecruitingNCT07768085

Shengjing Hospital40,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Interventions

AI-assisted abdominal CE-CT reportingOTHER

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.

Standard abdominal CE-CT reporting without AI assistanceOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age range 18 years and above 2. Underwent dynamic contrast-enhanced abdominal CT examination with liver coverage 3. Imaging must include at least three required phases: non-contrast, arterial phase, and venous phase; a delayed phase is optional 4. Complete imaging data that meet AI system and radiologist interpretation requirements. Exclusion Criteria: 1. 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 2. History of recent hepatic trauma (within 30 days) 3. Poor image quality or severe noise artifacts (e.g., metal or motion artifacts) 4. 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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts