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

November 30, 2021 updated by: University Ghent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:

  • Protheses or artificial implants, no magnetic or metal parts in the body
  • Being pregnant or breastfeeding
  • Having claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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))

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in grey matter volume before versus after MRI-upgrade
Time Frame: 7 months, 4 scan sessions of max 1 hour
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
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
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
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
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
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
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
7 months, 4 scan sessions of max 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

May 18, 2018

First Posted (Actual)

May 21, 2018

Study Record Updates

Last Update Posted (Actual)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 30, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • EC/2017/1103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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