Computer-Assisted Segmentation of Craniofacial Structures and Osteotomy Planning Using CBCT and CT
Development and Evaluation of Methods for Automatic and Semi-Automatic Segmentation of Craniofacial Structures and Delineation of Osteotomy Corridors Using CBCT and CT Imaging
This project will develop and evaluate methods for automatic and semi-automatic segmentation of craniofacial structures and delineation of osteotomy corridors using cone-beam computed tomography (CBCT) and computed tomography (CT) images. It will assess the quality and reproducibility of expert-prepared reference segmentations, the influence of model training, and the accuracy, processing time, and errors of automated methods. Only existing clinical scans will be used, with no additional imaging or changes to patient treatment.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This retrospective methodological project will use pseudonymized CBCT and CT images. Expert-reviewed segmentations and virtual osteotomy plans will serve as references. Selected cases will undergo repeated and independent assessment to evaluate intra- and interobserver agreement. A development dataset of CBCT examinations will be used to assess the effects of training set size and training progression. The final model will be tested on examinations not used during development. Evaluation will include segmentation accuracy, processing time, errors, technical failures, and correction requirements. Osteotomy corridors will be assessed against reference plans and nearby critical anatomical structures.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Maciej Sikora
- Numéro de téléphone: +48 41 260 55 85
- E-mail: sikora-maciej@wp.pl
Lieux d'étude
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Kielce, Pologne, 25-375
- Department of Maxillofacial Surgery, Hospital of the Ministry of Interior
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Contact:
- Maciej Sikora, dr hab.
- Numéro de téléphone: +48 41 260 55 85
- E-mail: sikora-maciej@wp.pl
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Patients aged 16-85 years at the time of clinically indicated CBCT or CT imaging, whose archived examinations meet the study eligibility criteria.
La description
Inclusion Criteria:
- Archived CBCT or CT examinations acquired for clinical indications.
- Patient age of 16-85 years at the time of imaging.
- Images available in DICOM format and suitable for analysis.
- Complete visualization of the anatomical structures required for the planned analysis.
- Image quality sufficient for reliable reference preparation and assessment.
Exclusion Criteria:
- Incomplete or corrupted image series.
- Insufficient imaging coverage.
- Image quality preventing reliable reference assessment.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: RETROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Patients with archived CBCT or CT examinations
Patients whose archived CBCT or CT examinations will be used to develop and evaluate automatic and semi-automatic craniofacial segmentation methods and virtual osteotomy planning. |
Automatic and semi-automatic segmentation of craniofacial structures and virtual delineation of osteotomy corridors using archived CBCT and CT images. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Segmentation accuracy compared with expert-prepared reference segmentations
Délai: At the time of final model evaluation, up to 6 months
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Agreement between uncorrected algorithm-generated segmentation masks and expert-prepared reference masks, assessed using the Dice similarity coefficient (DSC). Scores range from 0 to 1, with higher values indicating greater overlap. |
At the time of final model evaluation, up to 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intraobserver and interobserver agreement of reference segmentations
Délai: During initial, repeat, and independent reference segmentation assessments, up to 6 months
|
Agreement between repeated reference segmentations by the same investigator and independent reference segmentations by a second investigator, assessed using the Dice similarity coefficient (DSC). Scores range from 0 to 1, with higher values indicating greater overlap. |
During initial, repeat, and independent reference segmentation assessments, up to 6 months
|
|
Segmentation processing time
Délai: During segmentation processing, up to 6 months
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Time required to generate segmentations for the evaluated examinations. |
During segmentation processing, up to 6 months
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Frequency of segmentation errors, technical failures, and correction requirements
Délai: During segmentation processing and initial expert evaluation, up to 6 months
|
Frequency of segmentation errors, technical failures, restarts, and correction requirements, reported separately by category. |
During segmentation processing and initial expert evaluation, up to 6 months
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Segmentation performance by training set size and training progression
Délai: During model training and internal validation, up to 6 months
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Dice similarity coefficient values across evaluated training set sizes and training stages during internal validation. |
During model training and internal validation, up to 6 months
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Evaluation of virtual osteotomy corridors
Délai: At the time of virtual osteotomy corridor evaluation, up to 6 months
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Assessment of computer-generated osteotomy corridors against expert-prepared reference plans and in relation to nearby critical anatomical structures. |
At the time of virtual osteotomy corridor evaluation, up to 6 months
|
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
Autres numéros d'identification d'étude
- CT/2026/3
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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