Hearing Loss Clinical Trial
Official title:
Artificial Intelligence Driven Synthetic CT to Substitute CT Scans of the Head and Neck Region
Verified date | December 2023 |
Source | Amsterdam UMC, location VUmc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | September 12, 2023 |
Est. primary completion date | September 12, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients from the outpatient ENT (Ear, Nose, Throat)-clinic. - Aged 18 years or older. - Referred for CT scan of the mastoid, sinonasal complex or face. Exclusion Criteria: - Pregnancy. - Contra-indications for MRI or CT. - Unwillingness to be informed about possibly clinically relevant, incidental findings from the MRI examination. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam University Medical Center | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Amsterdam UMC, location VUmc | MRIguidance B.V. |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | Radiodensity accuracy. | Accuracy of the voxelwise radiodensity in Hounsfield Units and accuracy of the radiodensity contrast. | Within one year after scans have been obtained. | |
Primary | 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. | |
Secondary | 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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