MRI-based Synthetic CT Images of the Head and Neck

NCT06016335 | Completed

• 2 other identifiers: 2022.0234NL80426.029.22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

MRI; Synthetic CT; Artificial Intelligence; Craniofacial

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (1)

• Usefulness.

  Within one year after scans have been obtained.

Study Arms (2)

Training

OTHER

Data from 25-35 participants will be used to train an algorithm to generate synthetic CT images from MRI scans.

Diagnostic Test: CT scan; Diagnostic Test: MRI scan

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.

Diagnostic Test: CT scan; Diagnostic Test: MRI scan; Other: Synthetic CT scan

Interventions

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.

Testing; Training

MRI scan DIAGNOSTIC_TEST

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

Testing; Training

Synthetic CT scan OTHER

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

Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy.
• Contra-indications for MRI or CT.
• Unwillingness to be informed about possibly clinically relevant, incidental findings from the MRI examination.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• MRIguidance B.V.: collaborator

Study Sites (1)

Amsterdam University Medical Center

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Hearing Loss; Cholesteatoma; Sinusitis; Head and Neck Neoplasms

Interventions

Tomography, X-Ray Computed; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Paul Merkus, MD PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 29, 2023
• Study Start: September 22, 2022
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)