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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Maciej Sikora
- 电话号码：+48 41 260 55 85
- 邮箱：sikora-maciej@wp.pl
学习地点
-
-
-
Kielce、波兰、25-375
- Department of Maxillofacial Surgery, Hospital of the Ministry of Interior
-
接触：
- Maciej Sikora, dr hab.
- 电话号码：+48 41 260 55 85
- 邮箱：sikora-maciej@wp.pl
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients aged 16-85 years at the time of clinically indicated CBCT or CT imaging, whose archived examinations meet the study eligibility criteria.
描述
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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：OTHER
- 时间观点：RETROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Segmentation accuracy compared with expert-prepared reference segmentations
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intraobserver and interobserver agreement of reference segmentations
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CT/2026/3
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.