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MRI-based Synthetic CT Images of the Head and Neck

Primary Purpose

Imaging of Bony Structures of the Head (Various Conditions), Hearing Loss, Cholesteatoma

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
CT scan
MRI scan
Synthetic CT scan
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Imaging of Bony Structures of the Head (Various Conditions) focused on measuring MRI, Synthetic CT, Artificial Intelligence, Craniofacial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Amsterdam University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Training

Testing

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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".

Full Information

First Posted
August 7, 2023
Last Updated
August 25, 2023
Sponsor
Amsterdam UMC, location VUmc
Collaborators
MRIguidance B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT06016335
Brief Title
MRI-based Synthetic CT Images of the Head and Neck
Official Title
Artificial Intelligence Driven Synthetic CT to Substitute CT Scans of the Head and Neck Region
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
MRIguidance B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Imaging of Bony Structures of the Head (Various Conditions), Hearing Loss, Cholesteatoma, Sinusitis, Head and Neck Tumor
Keywords
MRI, Synthetic CT, Artificial Intelligence, Craniofacial

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training
Arm Type
Other
Arm Description
Data from 25-35 participants will be used to train an algorithm to generate synthetic CT images from MRI scans.
Arm Title
Testing
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
CT scan
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI scan
Intervention Description
Participants receive an MRI scan, specifically for the purpose of the study.
Intervention Type
Other
Intervention Name(s)
Synthetic CT scan
Intervention Description
Synthetic CT scans will be generated from MRI scans, using the trained machine learning algorithm.
Primary Outcome Measure Information:
Title
Geometrical accuracy.
Description
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.
Time Frame
Within one year after scans have been obtained.
Title
Radiodensity accuracy.
Description
Accuracy of the voxelwise radiodensity in Hounsfield Units and accuracy of the radiodensity contrast.
Time Frame
Within one year after scans have been obtained.
Title
Visibility of landmarks.
Description
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).
Time Frame
Within one year after scans have been obtained.
Secondary Outcome Measure Information:
Title
Usefulness.
Description
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".
Time Frame
Within one year after scans have been obtained.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Merkus, MD PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam University Medical Center
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MRI-based Synthetic CT Images of the Head and Neck

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