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OpenTrials
Completed

NCT Number: NCT06016335

MRI-based Synthetic CT Images of the Head and Neck

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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Key information

Conditions

Imaging of Bony Structures of the Head (Various Conditions) Cholesteatoma Ear Diseases Head and Neck Neoplasms Head and Neck Tumor Hearing Disorders Hearing Loss Infections Keratosis Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Sensation Disorders Signs and Symptoms Sinusitis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam University Medical Center

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

MRI scan

Diagnostic Test

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

Synthetic CT scan

Other

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

Primary outcomes

  1. Geometrical accuracy.

    Time frame: 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.

  2. Radiodensity accuracy.

    Time frame: Within one year after scans have been obtained.

    Accuracy of the voxelwise radiodensity in Hounsfield Units and accuracy of the radiodensity contrast.

  3. Visibility of landmarks.

    Time frame: 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 outcomes

  1. Usefulness.

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • MRIguidance B.V.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2023
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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