Comparing Brain Images Before and After MRI-upgrade - TimFit Upgrade Study

• Sponsor: University Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT03531580
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neuroimaging; Quality Control	Device: Magnetic Resonance Imaging	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Brain Images Before and After Upgrade of the MRI-scanner (Siemens Tim TRIO vs Siemens PRISMA FIT) - The TimFit Study
• Actual Study Start Date: Nov 29, 2017
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Jun 30, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Healthy volunteers six healthy volunteers: 3 male (age 20-40; 40-60 and 60+) and 3 female (age 20-40; 40-60 and 60+)

Device: Magnetic Resonance Imaging; 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))

Outcome Measures

Primary Outcome Measures

1. Change in grey matter volume before versus after MRI-upgrade [7 months, 4 scan sessions of max 1 hour]

2. Change in cerebral perfusion (ml/100g/min) using Arterial Spin Labeling before versus after MRI-upgrade [7 months, 4 scan sessions of max 1 hour]

3. Change in arterial transit times before versus after MRI-upgrade [7 months, 4 scan sessions of max 1 hour]

4. Change in functional connectivity (fc) using Resting State functional MRI before versus after MRI-upgrade [7 months, 4 scan sessions of max 1 hour]

5. Change in effective connectivity using resting state functional MRI before versus after MRI-upgrade [7 months, 4 scan sessions of max 1 hour]

6. Change in white matter diffusion before versus after MRI-upgrade [7 months, 4 scan sessions of max 1 hour]

7. Difference in image quality of FLAIR image before versus after MRI-upgrade [7 months, 4 scan sessions of max 1 hour]

8. Difference in image quality of SWI image before versus after MRI-upgrade [7 months, 4 scan sessions of max 1 hour]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy volunteer

Exclusion Criteria:

• Protheses or artificial implants, no magnetic or metal parts in the body

• Being pregnant or breastfeeding

• Having claustrophobia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghent University	Ghent		Belgium	9000

Sponsors and Collaborators

• University Ghent

Investigators

• Principal Investigator: Eric Achten, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Ghent
• ClinicalTrials.gov Identifier: NCT03531580
• Other Study ID Numbers: EC/2017/1103
• First Posted: May 21, 2018
• Last Update Posted: Dec 1, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 1, 2021