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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Maciej Sikora
- Número de teléfono: +48 41 260 55 85
- Correo electrónico: sikora-maciej@wp.pl
Ubicaciones de estudio
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Kielce, Polonia, 25-375
- Department of Maxillofacial Surgery, Hospital of the Ministry of Interior
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Contacto:
- Maciej Sikora, dr hab.
- Número de teléfono: +48 41 260 55 85
- Correo electrónico: sikora-maciej@wp.pl
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients aged 16-85 years at the time of clinically indicated CBCT or CT imaging, whose archived examinations meet the study eligibility criteria.
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: RETROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Segmentation accuracy compared with expert-prepared reference segmentations
Periodo de tiempo: 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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intraobserver and interobserver agreement of reference segmentations
Periodo de tiempo: During initial, repeat, and independent reference segmentation assessments, up to 6 months
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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
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Segmentation processing time
Periodo de tiempo: 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
Periodo de tiempo: During segmentation processing and initial expert evaluation, up to 6 months
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CT/2026/3
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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