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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Maciej Sikora
- Número de telefone: +48 41 260 55 85
- E-mail: sikora-maciej@wp.pl
Locais de estudo
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Kielce, Polônia, 25-375
- Department of Maxillofacial Surgery, Hospital of the Ministry of Interior
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Contato:
- Maciej Sikora, dr hab.
- Número de telefone: +48 41 260 55 85
- E-mail: sikora-maciej@wp.pl
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients aged 16-85 years at the time of clinically indicated CBCT or CT imaging, whose archived examinations meet the study eligibility criteria.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: OTHER
- Perspectivas de Tempo: RETROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Segmentation accuracy compared with expert-prepared reference segmentations
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Intraobserver and interobserver agreement of reference segmentations
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- CT/2026/3
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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