NeuroimagingNCT03531580
Comparing Brain Images Before and After MRI-upgrade - TimFit Upgrade Study
A study testing Magnetic Resonance Imaging in people with Neuroimaging and Quality Control, run by University Ghent at 1 site in Belgium.
Trial summary
In the Ghent University, an upgrade of the MRI-scanner used for research from Siemens Trio Tim to Siemens Prisma Fit is planned in the near future. As a change of MRI hard- and software might influence brain images, it is necessary to evaluate the images before and after the upgrade. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuroimaging, Quality Control
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Nov 2017to 30 Jun 2018
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer
Who cannot join
- Protheses or artificial implants, no magnetic or metal parts in the body
- Being pregnant or breastfeeding
- Having claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Images Before and After Upgrade of the MRI-scanner (Siemens Tim TRIO vs Siemens PRISMA FIT) - The TimFit Study
In the Ghent University, an upgrade of the MRI-scanner used for research from Siemens Trio Tim to Siemens Prisma Fit is planned in the near future. As a change of MRI hard- and software might influence brain images, it is necessary to evaluate the images before and after the upgrade.
- Conditions
- Neuroimaging, Quality Control
- Being tested
- Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
Brain imaging using magnetic resonance imaging, using several MRI sequences: structural imaging (grey matter, using T1-imaging), cerebral perfusion using arterial spin labeling), functional and effective connectivity (using resting-state functional MRI), white matter tracts (using diffusion imaging), white matter lesions (using Fluid-attenuated inversion recovery MRI (FLAIR)) and microbleeds (using Susceptibility weighted imaging (SWI))
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | six healthy volunteers: 3 male (age 20-40; 40-60 and 60+) and 3 female (age 20-40; 40-60 and 60+) Receives: Device: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in grey matter volume before versus after MRI-upgrade
Measured: 7 months, 4 scan sessions of max 1 hour
Change in cerebral perfusion (ml/100g/min) using Arterial Spin Labeling before versus after MRI-upgrade
Measured: 7 months, 4 scan sessions of max 1 hour
Change in arterial transit times before versus after MRI-upgrade
Measured: 7 months, 4 scan sessions of max 1 hour
Change in functional connectivity (fc) using Resting State functional MRI before versus after MRI-upgrade
Measured: 7 months, 4 scan sessions of max 1 hour
Change in effective connectivity using resting state functional MRI before versus after MRI-upgrade
Measured: 7 months, 4 scan sessions of max 1 hour
Change in white matter diffusion before versus after MRI-upgrade
Measured: 7 months, 4 scan sessions of max 1 hour
Difference in image quality of FLAIR image before versus after MRI-upgrade
Measured: 7 months, 4 scan sessions of max 1 hour
Difference in image quality of SWI image before versus after MRI-upgrade
Measured: 7 months, 4 scan sessions of max 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start29 Nov 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroimagingStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Achten, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531580
- Sponsor's protocol ID
- EC/2017/1103
- Status last verified
- Nov 2021
- First submitted
- 20 Nov 2017
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Images Before and After Upgrade of the MRI-scanner (Siemens Tim TRIO vs Siemens PRISMA FIT) - The TimFit Study
- ClinicalTrials.gov ID
- NCT03531580
- Acronym / sponsor ID
- EC/2017/1103
- Conditions
- Neuroimaging, Quality Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 21 May 2018 (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 the Ghent University, an upgrade of the MRI-scanner used for research from Siemens Trio Tim to Siemens Prisma Fit is planned in the near future. As a change of MRI hard- and software might influence brain images, it is necessary to evaluate the images before and after the upgrade.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Device: Magnetic Resonance Imagingsix healthy volunteers: 3 male (age 20-40; 40-60 and 60+) and 3 female (age 20-40; 40-60 and 60+) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteer
Key exclusion criteria (3 listed)
- Protheses or artificial implants, no magnetic or metal parts in the body
- Being pregnant or breastfeeding
- Having claustrophobia
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 |
|---|---|---|
| Magnetic Resonance ImagingBrain imaging using magnetic resonance imaging, using several MRI sequences: structural imaging (grey matter, using T1-imaging), cerebral perfusion using arterial spin labeling), functional and effective connectivity (using resting-state functional MRI), white matter tracts (using diffusion imaging), white matter lesions (using Fluid-attenuated inversion recovery MRI (FLAIR)) and microbleeds (using Susceptibility weighted imaging (SWI)) | Device | Healthy volunteers |
Primary outcome
Change in grey matter volume before versus after MRI-upgrade
Time frame: 7 months, 4 scan sessions of max 1 hour
Change in cerebral perfusion (ml/100g/min) using Arterial Spin Labeling before versus after MRI-upgrade
Time frame: 7 months, 4 scan sessions of max 1 hour
Change in arterial transit times before versus after MRI-upgrade
Time frame: 7 months, 4 scan sessions of max 1 hour
Change in functional connectivity (fc) using Resting State functional MRI before versus after MRI-upgrade
Time frame: 7 months, 4 scan sessions of max 1 hour
Change in effective connectivity using resting state functional MRI before versus after MRI-upgrade
Time frame: 7 months, 4 scan sessions of max 1 hour
Change in white matter diffusion before versus after MRI-upgrade
Time frame: 7 months, 4 scan sessions of max 1 hour
Difference in image quality of FLAIR image before versus after MRI-upgrade
Time frame: 7 months, 4 scan sessions of max 1 hour
Difference in image quality of SWI image before versus after MRI-upgrade
Time frame: 7 months, 4 scan sessions of max 1 hour
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 1 Dec 2021.
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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.
Eric Achten, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging in people with Neuroimaging and Quality Control, run by University Ghent 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 1 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 1 Dec 2021. 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?
Change in grey matter volume before versus after MRI-upgrade (time frame: 7 months, 4 scan sessions of max 1 hour). The study lists 8 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 1 Dec 2021.