- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07929532
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Maciej Sikora
- Telefonnummer: +48 41 260 55 85
- E-mail: sikora-maciej@wp.pl
Studiesteder
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Kielce, Polen, 25-375
- Department of Maxillofacial Surgery, Hospital of the Ministry of Interior
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Kontakt:
- Maciej Sikora, dr hab.
- Telefonnummer: +48 41 260 55 85
- E-mail: sikora-maciej@wp.pl
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Patients aged 16-85 years at the time of clinically indicated CBCT or CT imaging, whose archived examinations meet the study eligibility criteria.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: OTHER
- Tidsperspektiver: RETROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Segmentation accuracy compared with expert-prepared reference segmentations
Tidsramme: At the time of final model evaluation, up to 6 months
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Intraobserver and interobserver agreement of reference segmentations
Tidsramme: 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
Tidsramme: During segmentation processing, up to 6 months
|
Time required to generate segmentations for the evaluated examinations. |
During segmentation processing, up to 6 months
|
|
Frequency of segmentation errors, technical failures, and correction requirements
Tidsramme: 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
|
|
Segmentation performance by training set size and training progression
Tidsramme: During model training and internal validation, up to 6 months
|
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
|
|
Evaluation of virtual osteotomy corridors
Tidsramme: At the time of virtual osteotomy corridor evaluation, up to 6 months
|
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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CT/2026/3
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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