AI-Assisted Chest CT Interpretation Across the Lung Cancer Care Continuum
Development of a Chest CT-Based Artificial Intelligence Model Across the Lung Cancer Care Continuum and a Prospective Randomized Crossover Reader Study of Its Clinical Decision-Support Performance
This investigator-initiated, single-center study consists of a retrospective artificial intelligence model-development stage and a prospective physician reader-study stage. Deidentified chest CT examinations acquired during routine clinical care between January 1, 2021, and December 31, 2024, will be used to develop, validate, and lock artificial intelligence models for lung cancer-related imaging tasks.
In the prospective stage, approximately 12 to 15 physicians with experience in chest CT interpretation will complete two reading sessions in randomized order: unaided interpretation and AI-assisted interpretation. The sessions will be separated by a washout period of at least 4 weeks. The primary objective is to compare diagnostic performance between AI-assisted and unaided interpretation. Secondary objectives include reading time, diagnostic confidence, inter-reader agreement, and errors related to incorrect AI suggestions.
All readings will be performed in an offline research environment. AI outputs will not be used for patient care, and the study will not add imaging examinations, treatment, or follow-up for patients.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lian Yang, PhD
- Numéro de téléphone: +86 18986273791
- E-mail: yanglian@hust.edu.cn
Lieux d'étude
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Hubei
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Wuhan, Hubei, Chine, 430022
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Contact:
- Lian Yang, PhD
- Numéro de téléphone: +86 18986273791
- E-mail: yanglian@hust.edu.cn
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Physicians with education or training relevant to medical imaging
- Experience in interpreting chest CT examinations
- Ability to complete the required study training and both reading sessions
- Willingness to provide written informed consent and comply with study procedures
Exclusion Criteria:
- Failure to complete the required study training
- Inability or unwillingness to complete both reading sessions as required
- Any protocol deviation likely to compromise the validity of the reader-study data
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Sequence AB: Unaided Then AI-Assisted Interpretation
Participants first complete an unaided chest CT interpretation session. After a washout period of at least 4 weeks, they complete an AI-assisted interpretation session. |
A locked research-use-only artificial intelligence system analyzes deidentified chest CT images and provides decision-support outputs to participating physicians. The system is evaluated only in an offline reader-study environment and is not used for actual patient care. |
|
Expérimental: Sequence BA: AI-Assisted Then Unaided Interpretation
Participants first complete an AI-assisted chest CT interpretation session. After a washout period of at least 4 weeks, they complete an unaided interpretation session. |
A locked research-use-only artificial intelligence system analyzes deidentified chest CT images and provides decision-support outputs to participating physicians. The system is evaluated only in an offline reader-study environment and is not used for actual patient care. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in Diagnostic Accuracy Between AI-Assisted and Unaided Chest CT Interpretation
Délai: At completion of the second reading session, after a washout period of at least 4 weeks
|
Diagnostic accuracy will be calculated as the proportion of case-level interpretations that agree with the prespecified reference standard based on pathology or clinical follow-up. The paired difference in diagnostic accuracy between AI-assisted and unaided interpretation will be estimated across participating physicians and cases using a multi-reader multi-case analysis and reported with a 95% confidence interval. Higher accuracy indicates better diagnostic performance. |
At completion of the second reading session, after a washout period of at least 4 weeks
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Radio-20260816
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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