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| ID | Type | Description | Link |
|---|---|---|---|
| NL80426.029.22 | Registry Identifier | CCMO Register |
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| Name | Class |
|---|---|
| MRIguidance B.V. | INDUSTRY |
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In case of surgical procedures in the head and neck region, MRI in combination with CT of the bone is often the standard modality to visualise bony landmarks for planning, navigation and risk assessment. An important downside of a CT scan is the associated radiation exposure, especially in children. An additional downside is the sedation or general anaesthesia needed for both the MRI and CT scan session in very young children. These downsides could be removed if the CT scan can be substituted by an MRI sequence that can provide the same information as CT. This project aims to determine the feasibility of recreating CT like images of the craniofacial bones from MRI images using machine learning techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training | Other | Data from 25-35 participants will be used to train an algorithm to generate synthetic CT images from MRI scans. |
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| Testing | Other | Data from remaining participants will be used to test the synthetic CT algorithm, by comparing true CT scans to synthetic CT scans made from MRI. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT scan | Diagnostic Test | Participants receive a CT scan of the head as part of their regular care. A larger part of the head will be scanned than for standard care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometrical accuracy. | Geometrical accuracy of the bone morphology by determining the mean surface distance in mm between the cortical edges on synthetic CT and on true CT. | Within one year after scans have been obtained. |
| Radiodensity accuracy. | Accuracy of the voxelwise radiodensity in Hounsfield Units and accuracy of the radiodensity contrast. | Within one year after scans have been obtained. |
| Visibility of landmarks. | Accuracy of the visibility of clinically relevant anatomical landmarks on the synthetic CT images compared to the corresponding true CT images in the adult population, rated by experienced physicians on a 4-point Likert scale (1 = not visible, 4 = very well visible). | Within one year after scans have been obtained. |
| Measure | Description | Time Frame |
|---|---|---|
| Usefulness. | Evaluation of potential usefulness of the synthetic CT images for surgical planning, surgical navigation and diagnostic purposes, as evaluated by experienced physicians and dichotomised into "useful" or "not useful". | Within one year after scans have been obtained. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Merkus, MD PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam University Medical Center | Amsterdam | Netherlands |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D002781 | Cholesteatoma |
| D012852 | Sinusitis |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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For all participants the same research activities will be performed (namely CT and MRI). The resulting paired MRI and CT scans will then be divided into a training set and a test set.
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| MRI scan | Diagnostic Test | Participants receive an MRI scan, specifically for the purpose of the study. |
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| Synthetic CT scan | Other | Synthetic CT scans will be generated from MRI scans, using the trained machine learning algorithm. |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |