NCT03531580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

November 29, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

November 20, 2017

Last Update Submit

November 30, 2021

Conditions

NeuroimagingQuality Control

Outcome Measures

Primary Outcomes (8)

  • Change in grey matter volume before versus after MRI-upgrade

    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

    7 months, 4 scan sessions of max 1 hour

  • Change in arterial transit times before versus after MRI-upgrade

    7 months, 4 scan sessions of max 1 hour

  • Change in functional connectivity (fc) using Resting State functional MRI before versus after MRI-upgrade

    7 months, 4 scan sessions of max 1 hour

  • Change in effective connectivity using resting state functional MRI before versus after MRI-upgrade

    7 months, 4 scan sessions of max 1 hour

  • Change in white matter diffusion before versus after MRI-upgrade

    7 months, 4 scan sessions of max 1 hour

  • Difference in image quality of FLAIR image before versus after MRI-upgrade

    7 months, 4 scan sessions of max 1 hour

  • Difference in image quality of SWI image before versus after MRI-upgrade

    7 months, 4 scan sessions of max 1 hour

Study Arms (1)

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+)

Device: Magnetic Resonance Imaging

Interventions

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))

Healthy volunteers

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Eric Achten, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

May 21, 2018

Study Start

November 29, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

December 1, 2021

Record last verified: 2021-11

Locations

BE(1)