Imaging of Bony Structures of the Head (Various Conditions)NCT06016335
MRI-based Synthetic CT Images of the Head and Neck
A study testing CT scan, MRI scan and Synthetic CT scan in people with Imaging of Bony Structures of the Head (Various Conditions) and Hearing Loss, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Imaging of Bony Structures of the Head (Various Conditions), Hearing Loss, Cholesteatoma
- What is being tested?
- CT scan, MRI scan and Synthetic CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Sep 2022to 12 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy.
- Contra-indications for MRI or CT.
- Unwillingness to be informed about possibly clinically relevant, incidental findings from the MRI examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Intelligence Driven Synthetic CT to Substitute CT Scans of the Head and Neck Region
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
- Being tested
- CT scan, MRI scan, Synthetic CT scan
- Keywords
- MRI, Synthetic CT, Artificial Intelligence, Craniofacial
- Medical subject headings
- Hearing Loss, Cholesteatoma, Sinusitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic 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 scanDiagnostic test
Participants receive an MRI scan, specifically for the purpose of the study.
Synthetic CT scanOther
Synthetic CT scans will be generated from MRI scans, using the trained machine learning algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Training | Other | Data from 25-35 participants will be used to train an algorithm to generate synthetic CT images from MRI scans. Receives: 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. Receives: Diagnostic Test: CT scan; Diagnostic Test: MRI scan; Other: Synthetic CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one year after scans have been obtained.
Radiodensity accuracy.
Accuracy of the voxelwise radiodensity in Hounsfield Units and accuracy of the radiodensity contrast.
Measured: 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).
Measured: Within one year after scans have been obtained.
Secondary outcomes (1)
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".
Measured: Within one year after scans have been obtained.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start22 Sep 2022
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Imaging of Bony Structures of the Head (Various Conditions)Studies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- MRIguidance B.V.
- Responsible party
- Principal investigator, Paul Merkus, Amsterdam UMC, location VUmc
- Investigators
- Paul Merkus, MD PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016335
- Sponsor's protocol ID
- 2022.0234
- Other IDs
- NL80426.029.22
- Status last verified
- Dec 2023
- First submitted
- 7 Aug 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Driven Synthetic CT to Substitute CT Scans of the Head and Neck Region
- ClinicalTrials.gov ID
- NCT06016335
- Acronym / sponsor ID
- 2022.0234
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- MRIguidance B.V.
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Training | Other | Diagnostic Test: CT scan, Diagnostic Test: MRI scanData from 25-35 participants will be used to train an algorithm to generate synthetic CT images from MRI scans. |
| Testing | Other | Diagnostic Test: CT scan, Diagnostic Test: MRI scan, Other: Synthetic CT scanData from remaining participants will be used to test the synthetic CT algorithm, by comparing true CT scans to synthetic CT scans made from MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnancy.
- Contra-indications for MRI or CT.
- Unwillingness to be informed about possibly clinically relevant, incidental findings from the MRI examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanParticipants 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 test | Testing, Training |
| MRI scanParticipants receive an MRI scan, specifically for the purpose of the study. | Diagnostic test | Testing, Training |
| Synthetic CT scanSynthetic CT scans will be generated from MRI scans, using the trained machine learning algorithm. | Other | Testing |
Primary outcome
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.
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.
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).
1 secondary outcome
Usefulness.
Time frame: Within one year after scans have been obtained.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Merkus, MD PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan, MRI scan and Synthetic CT scan in people with Imaging of Bony Structures of the Head (Various Conditions) and Hearing Loss, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometrical accuracy. (time frame: Within one year after scans have been obtained.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.