MRI-based Synthetic CT Images of the Head and Neck

Hearing Loss Clinical Trial

Official title:

Artificial Intelligence Driven Synthetic CT to Substitute CT Scans of the Head and Neck Region

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06016335
• Other study ID #: 2022.0234
• Secondary ID: NL80426.029.22
• Status: Completed
• Phase: N/A
• Start date: September 22, 2022
• Est. completion date: September 12, 2023

Study information

• Verified date: December 2023
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cholesteatoma
• Head and Neck Neoplasms
• Head and Neck Tumor
• Hearing Loss
• Sinusitis

Intervention

Diagnostic Test:
• CT scan
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.
• MRI scan
Participants receive an MRI scan, specifically for the purpose of the study.

Other:
• Synthetic CT scan
Synthetic CT scans will be generated from MRI scans, using the trained machine learning algorithm.

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Center	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc	MRIguidance B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

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.