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

14 août 2026 mis à jour par: Yu Shi, Shengjing Hospital

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

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

40000

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Liaoning
      • Shenyang, Liaoning, Chine, 110004
        • Shengjing Hospital of China Medical University
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: AI-on: AI-assisted abdominal CE-CT reporting
Intervention: AI-assisted interpretation of abdominal CE-CT
Autre: AI-assisted abdominal CE-CT reporting
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.
Comparateur actif: AI-off: Standard abdominal CE-CT reporting without AI assistance
Routine interpretation of abdominal CE-CT without access to AI system (standard of care)
Autre: Standard abdominal CE-CT reporting without AI assistance
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Per-participant rate of missed clinically significant liver malignancy
Délai: From the index CE-CT examination through 12 months
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.
From the index CE-CT examination through 12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Senior-review workload
Délai: Up to 24 hours after the eligible CE-CT examination becomes available for interpretation
Number of examinations requiring senior radiologist review per 100 eligible CE-CT examinations, compared between AI-assisted and standard-reporting center-days.
Up to 24 hours after the eligible CE-CT examination becomes available for interpretation
Final report turnaround time
Délai: Up to 24 hours after the complete CE-CT examination becomes available for interpretation
Time in minutes from availability of the complete CE-CT examination for interpretation to authorization of the final clinical report.
Up to 24 hours after the complete CE-CT examination becomes available for interpretation
Detection rate of clinically significant malignant liver lesions
Délai: From the index CE-CT examination through 12 months
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.
From the index CE-CT examination through 12 months
Clinically appropriate management-change rate
Délai: From the index CE-CT examination through 12 months
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.
From the index CE-CT examination through 12 months
Time to initiation of treatment for liver malignancy
Délai: From the index CE-CT examination through 12 months
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.
From the index CE-CT examination through 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shengjing Hospital

Les enquêteurs

  • Chercheur principal: Yu Shi, MD, Shengjing Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

17 août 2026

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

11 août 2026

Première soumission répondant aux critères de contrôle qualité

14 août 2026

Première publication (Réel)

17 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SH-Lion2RCT--Intervention

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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