CT database for evaluation of automatic image segmentation programs in the maxillofacial area
Organizational Data
- DRKS-ID:
- DRKS00014853
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2018-06-29
- Last update in DRKS:
- 2024-02-05
- Registration type:
- Prospective
Acronym/abbreviation of the study
enFacedDB
URL of the study
No Entry
Brief summary in lay language
Computer-assisted technologies such as image-based automatic segmentation play an important role in supporting diagnosis and therapy planning in the field of oral and maxillofacial surgery. Although numerous such image-based segmentation methods exist, their clinical application is often very limited. This particularly applies to freely accessible segmentation methods in relation to systematic evaluation. The aim of this study is therefore to assess the quality of segmentation programs in the maxillofacial skull. The assessment is based on a comparison between segmented CT image data of the bones. Segmented clinical image data is compared with that of clinical experts. This study is a comparison of several freely accessible software platforms in the maxillofacial skull based on clinical CT data to improve potential clinical applications in the field of patient-individualized medicine in oral and maxillofacial surgery.
Brief summary in scientific language
Computer- assisted technologies such as image- based segmentation play an important in the diagnosis and treatment support in oral- and maxillofacial surgery. However, although many image- based segmentation approaches exist, their clinical in- house use is often strongly limited due to technical, human or financial resources. Especially in open- source based segmentation, systematic evaluations of segmentation approaches are lacking. Therefore, the aim of this study is to assess the real segmentation quality of commonly available and license- free segmentation programs in the maxillofacial area. The assessment is done in a comparison between segmented CT- image data of the maxillofacial area. Segmented patient- specific clinical image data performed by automatic segmentation algorithms are compared with the manual ground truth segmentations performed by clinical experts. Assessment parameters are amongst others the Dice Score Coefficient (DSC, %) and the Hausdorff Distance (HD, voxel). This study is a systematic comparison that evaluates multiple license- free, open- source segmentation programs and software platforms in the maxillofacial area based on clinical CT- data for the improvement of segmentation algorithms and a potential clinical use in patient-individualized medicine in the field of oral and maxillofacial surgery. Further, the results presented are reproducible by others and can be used for both clinical and research purposes.
Health condition or problem studied
- ICD10:
- S02 - Fracture of skull and facial bones
- ICD10:
- M85 - Other disorders of bone density and structure
- ICD10:
- Q75 - Other congenital malformations of skull and face bones
- ICD10:
- S09 - Other and unspecified injuries of head
- ICD10:
- K10 - Other diseases of jaws
- ICD10:
- K07 - Dentofacial anomalies [including malocclusion]
- ICD10:
- Z96 - Presence of other functional implants
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Establishment of a CT database (CT, PET/CT etc.) of the maxillofacial area with datasets from the clinical routine for the comparative evaluation of multiple image- based computer programs and platforms.
Endpoints
- Primary outcome:
- Comparison image based segmentation of maxillofacial CT- data between automatic (algorithm) vs. manual (clinical experts) at measurement point T by Hausdorff Distance (HD, voxel) and Dice Similarity Score (DSC, %).
- Secondary outcome:
- Comparison image based segmentation of maxillofacial CT- data between automatic (algorithm) vs. manual (clinical experts) at measurement point T by Volume (V, mm3), Voxel (Vx, Number), time (t, min., sec.).
Study Design
- Purpose:
- Basic research/physiological study
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Austria
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Medizinische Universität Graz Graz
Recruitment period and number of participants
- Planned study start date:
- 2018-07-01
- Actual study start date:
- 2018-08-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 100
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 99 Years
- Additional Inclusion Criteria:
- Physiologically functional, complete maxillofacial bones
Exclusion Criteria
• Implants or osteosynthesis material • Age <18 Years • Bone necrosis or pathologic-cystic changes of the bones
Addresses
Primary Sponsor
- Address:
- Medizinische Universität GrazDDDr. Jürgen WallnerAuenbruggerplatz 5/18036 GrazAustria
- Telephone:
- +43/316/385-12428
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.medunigraz.at/en/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Medizinische Universität GrazDDDr. Jürgen WallnerAuenbruggerplatz 5/18036 GrazAustria
- Telephone:
- +43/316/385-12428
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.medunigraz.at/en/
Contact for Public Queries
- Address:
- Medizinische Universität GrazDDDr. Jürgen WallnerAuenbruggerplatz 5/18036 GrazAustria
- Telephone:
- +43/316/385-12428
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.medunigraz.at/en/
Principal Investigator
- Address:
- Medizinische Universität GrazDDDr. Jürgen WallnerAuenbruggerplatz 5/18036 GrazAustria
- Telephone:
- +43/316/385-12428
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.medunigraz.at/en/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- FWFSensengasse 11090 WienAustria
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.fwf.ac.at/
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Austrian Science Fund (FWF) KLI 678-B31: “enFaced: Virtual and Augmented Reality Training and Navigation Module for 3D-Printed Facial Defect Reconstructions” (PIs: Jürgen Wallner and Jan Egger)1090 WienAustria
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Universität GrazAuenbruggerplatz 28036 GrazGermany
- Telephone:
- (+43)316-38513928
- Fax:
- (+43)316-38514348
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-04-17
- Ethics committee number:
- 30-340 ex 17/18
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-06-14
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Data obtained through this study may be provided to qualified researchers with academic interest in this study. Data or samples shared will be anomynized. Data will be shared only according to the internal review board's approval.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry