Magnetic Resonance ImagingNCT06278376
Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans
An observational study of Magnetic Resonance Imaging, run by Jessa Hospital at 1 site in Belgium.
Trial summary
The aim of this study is to evaluate the indications and therapeutical consequences of MRI scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim for a clear indication in children undergoing MRI in the future before undergoing possible unnecessary procedures and MRI scans. Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Magnetic Resonance Imaging
- How many people
- 410 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Apr 2023to 31 Dec 2024
- Phase
- Observational
- 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 6 months to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: The population for this study will be children between 6 months and 16 years old who have undergone an MRI scan in Jessa hospital (Hasselt, Belgium) between November 2016 and February 2023.
Who may be able to join
- Children undergoing an MRI scan in Jessa hospital (Hasselt, Belgium) between November 2016 and February 2023.
- Age between 6 months and 16 years
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans: a Retrospective, Longitudinal Study
The aim of this study is to evaluate the indications and therapeutical consequences of MRI scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim for a clear indication in children undergoing MRI in the future before undergoing possible unnecessary procedures and MRI scans.
Read the detailed description
Magnetic resonance imaging (MRI) is a non-invasive imaging technique that allows physicians to visualize our anatomy, generating high-quality pictures of our body's internal structure at many different angles. The principle behind MRI, known as nuclear magnetic resonance (NMR), revolves around hydrogen atoms (or protons) that can be found everywhere in our entire body, such as in bones, blood, organs, skin, muscles and more. Protons have their own magnetic moment and angular momentum, allowing them to spin in a certain direction. By subjecting these spinning protons to a strong magnetic field they will be oriented along the axis of the magnetic field, either with or against the direction of the magnetic field. MRI machines generate this field using a large magnet surrounding the patient. Electric gradient coils allow the strength of the field to be adjustable, usually around 0,5 or 1,5 tesla.
MRI has many advantages compared to other imaging techniques, i.e. CT (computed tomography), including the lack of radiation, the ability to show abnormalities of soft tissues, the ability to visualize blood flow, and contrasting agents that are less likely to cause adverse effects like allergic reactions. There are also some disadvantages or limitations, however: implants or metallic objects inside the body can make images unclear at best or harm the patient at worst; similarly, movements made by the patient can make images unclear as well. Lastly, MRI is a more expensive and slower technique compared to other imaging techniques.
Children undergoing an MRI are often sedated before being placed inside the machine. After the scan is over, the children will be brought to a recovery area, where they can slowly recover from the sedation until they are fully awake again. Some common side effects resulting from the sedation may be vomiting, drowsiness and/or dizziness.
The aim of this study is to evaluate the indications and therapeutical consequences of MRI scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim for a clear indication in children undergoing MRI in the future before undergoing possible unnecessary procedures and MRI scans.
- Conditions
- Magnetic Resonance Imaging
- Keywords
- Magnetic Resonance Imaging, Childeren
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
Incidence of diagnostic MRI in childeren
Measured: Between 2016 and 2023
Secondary outcomes (11)
Therapeutical implications: diagnosis
Evaluating the presence of a diagnosis after this MRI investigation
Measured: Between 2016 and 2023
Therapeutical implications: treatment
Evaluating if the MRI investigation resulted in treatment (drug treatment, surgery or physiotherapy)
Measured: Between 2016 and 2023
Clinical indications
Evaluating the clinical indications for the MRI investigation
Measured: Between 2016 and 2023
Evaluation of body part
Evaluating which specific body parts are undergoing imaging
Measured: Between 2016 and 2023
Evaluation of symptoms
Evaluation of the pre-existing symptoms (vomiting, headache, developmental delay, sleep issures, swellings, seizures, balance problems, conduct disorders, febrile convulsions) that potentially lead to an MRI scan
Measured: Between 2016 and 2023
Clinical outcome: adverse event
Evaluation of the clinical outcome: adverse events
Measured: Between 2016 and 2023
Clinical outcome: surgery
Evaluation of the clinical outcome: surgery after MRI
Measured: Between 2016 and 2023
Clinical outcome: admission to hospital
Evaluation of the clinical outcome: admission to hospital
Measured: Between 2016 and 2023
Clinical outcome: mortality
Evaluation of the clinical outcome: mortality after MRI
Measured: Between 2016 and 2023
Evaluation of age
Evaluation of age in children: <2 years, 2-6 years and >6 years
Measured: Between 2016 and 2023
Influence of COVID-19 pandemic
Influence of COVID-19 pandemic (2020-2021 versus 2016-2017-2018-2019-2022-2023) on incidence, therapeutical implications and outcomes of MRI scans in children
Measured: Between 2016 and 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start25 Apr 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278376
- Sponsor's protocol ID
- f/2023/045
- Status last verified
- May 2025
- First submitted
- 1 Feb 2024
- Last updated
- 14 May 2025
- 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans: a Retrospective, Longitudinal Study
- ClinicalTrials.gov ID
- NCT06278376
- Acronym / sponsor ID
- f/2023/045
- Conditions
- Magnetic Resonance Imaging
- Keywords
- Magnetic Resonance Imaging, Childeren
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Feb 2024 (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.
The aim of this study is to evaluate the indications and therapeutical consequences of MRI scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim for a clear indication in children undergoing MRI in the future before undergoing possible unnecessary procedures and MRI scans.
Detailed description
Magnetic resonance imaging (MRI) is a non-invasive imaging technique that allows physicians to visualize our anatomy, generating high-quality pictures of our body's internal structure at many different angles. The principle behind MRI, known as nuclear magnetic resonance (NMR), revolves around hydrogen atoms (or protons) that can be found everywhere in our entire body, such as in bones, blood, organs, skin, muscles and more. Protons have their own magnetic moment and angular momentum, allowing them to spin in a certain direction. By subjecting these spinning protons to a strong magnetic field they will be oriented along the axis of the magnetic field, either with or against the direction of the magnetic field. MRI machines generate this field using a large magnet surrounding the patient. Electric gradient coils allow the strength of the field to be adjustable, usually around 0,5 or 1,5 tesla.
MRI has many advantages compared to other imaging techniques, i.e. CT (computed tomography), including the lack of radiation, the ability to show abnormalities of soft tissues, the ability to visualize blood flow, and contrasting agents that are less likely to cause adverse effects like allergic reactions. There are also some disadvantages or limitations, however: implants or metallic objects inside the body can make images unclear at best or harm the patient at worst; similarly, movements made by the patient can make images unclear as well. Lastly, MRI is a more expensive and slower technique compared to other imaging techniques.
Children undergoing an MRI are often sedated before being placed inside the machine. After the scan is over, the children will be brought to a recovery area, where they can slowly recover from the sedation until they are fully awake again. Some common side effects resulting from the sedation may be vomiting, drowsiness and/or dizziness.
The aim of this study is to evaluate the indications and therapeutical consequences of MRI scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim for a clear indication in children undergoing MRI in the future before undergoing possible unnecessary procedures and MRI scans.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The population for this study will be children between 6 months and 16 years old who have undergone an MRI scan in Jessa hospital (Hasselt, Belgium) between November 2016 and February 2023.
Key inclusion criteria (2 listed)
- Children undergoing an MRI scan in Jessa hospital (Hasselt, Belgium) between November 2016 and February 2023.
- Age between 6 months and 16 years
Key exclusion criteria (1 listed)
- /
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence
Time frame: Between 2016 and 2023
Incidence of diagnostic MRI in childeren
11 secondary outcomes
Therapeutical implications: diagnosis
Time frame: Between 2016 and 2023
Therapeutical implications: treatment
Time frame: Between 2016 and 2023
Clinical indications
Time frame: Between 2016 and 2023
Evaluation of body part
Time frame: Between 2016 and 2023
Evaluation of symptoms
Time frame: Between 2016 and 2023
Clinical outcome: adverse event
Time frame: Between 2016 and 2023
Clinical outcome: surgery
Time frame: Between 2016 and 2023
Clinical outcome: admission to hospital
Time frame: Between 2016 and 2023
Clinical outcome: mortality
Time frame: Between 2016 and 2023
Evaluation of age
Time frame: Between 2016 and 2023
Influence of COVID-19 pandemic
Time frame: Between 2016 and 2023
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 14 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Resonance Imaging, run by Jessa Hospital at 1 site in Belgium.
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 2 inclusion and 1 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 14 May 2025. 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 Belgium. 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?
Incidence (time frame: Between 2016 and 2023). 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 14 May 2025.