- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03531580
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
-
-
-
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+)
|
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
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.
Clinical Trials on Neuroimaging
-
Northwell HealthWithdrawn
-
Centre Hospitalier Universitaire de BesanconUniversity of Franche-ComtéCompleted
-
Hospices Civils de LyonRecruitingBehaviors | Driving | Automation | NeuroimagingFrance
-
GE HealthcareWellcome TrustCompletedNeonatal NeuroimagingUnited Kingdom
-
University of BonnCompleted
-
University Hospital Inselspital, BerneEnrolling by invitationNeuroimaging | Autofluorescence ImagingSwitzerland
-
Robin Carhart-Harris, PhD, MARecruitingHealthy Volunteers | Psychedelic Experiences | NeuroimagingUnited States
-
Chinese University of Hong KongPrince of Wales Hospital, Shatin, Hong KongCompletedNeuroimaging | Lexical Tone | Chinese | Speech PerceptionChina
-
Centre Hospitalier Universitaire, AmiensActive, not recruiting
-
Northumbria UniversityFinzelbergCompletedCognitive Change | Blood Pressure | Affect | NeuroimagingUnited Kingdom
Clinical Trials on Magnetic Resonance Imaging
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Recruiting
-
M.D. Anderson Cancer CenterActive, not recruitingProstate Adenocarcinoma | Prostate CarcinomaUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Healthy SubjectUnited States
-
Stanford UniversityTerminatedLaryngeal Neoplasms | Head and Neck Cancers | Larynx CancerUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityRecruitingIntracranial NeoplasmUnited States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)CompletedBreast CancerUnited States
-
University of California, San FranciscoTerminatedAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
Abramson Cancer Center of the University of PennsylvaniaCompletedBrain TumorUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedThoracic Spine NeoplasmUnited States