MRI-based Synthetic CT Images of the Head and Neck

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06016335

Enrollment

Registered

2023-08-29

Start date

2022-09-22

Completion date

2023-09-12

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholesteatoma, Head and Neck Tumor, Hearing Loss, Imaging of Bony Structures of the Head (Various Conditions), Sinusitis

Keywords

MRI, Synthetic CT, Artificial Intelligence, Craniofacial

Brief 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.

Interventions

DIAGNOSTIC_TESTCT 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.

DIAGNOSTIC_TESTMRI scan

Participants receive an MRI scan, specifically for the purpose of the study.

OTHERSynthetic CT scan

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Geometrical accuracy.	Within one year after scans have been obtained.	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.
Radiodensity accuracy.	Within one year after scans have been obtained.	Accuracy of the voxelwise radiodensity in Hounsfield Units and accuracy of the radiodensity contrast.
Visibility of landmarks.	Within one year after scans have been obtained.	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).

Secondary

Measure	Time frame	Description
Usefulness.	Within one year after scans have been obtained.	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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026