Scan-rescan Reproducibility of Myelin Sensitive MRI Techniques

NCT04673734 | Completed

• 1 other identifier: 2020-02826; me20Granziera3
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assess the variation in the measurements of myelin sensitive MRI techniques in both white and grey matter in the brain.

Conditions

Myelin Integrity

Keywords

Magnetization Transfer Imaging (MTI); Multi-echo Susceptibility-Based imaging (SBI); Myelin Water Imaging (MWI); T1 relaxometry (quantitative T1, qT1); multi-shell diffusion; myelin sensitive MRI techniques

Outcome Measures

Primary Outcomes (1)

• analysis of variance between MTI, SBI, MWI, T1 relaxometry and multi-shell diffusion obtained in each subject in each of the 3 scan sessions

  statistical analysis of variance between MTI, SBI, MWI, T1 relaxometry and multi-shell diffusion obtained in each subject in each of the 3 scan sessions

  1 hour total scan time (during a time period of max. 1 week)

Interventions

myelin sensitive MRI scan DIAGNOSTIC_TEST

Acquisition of 3 myelin sensitive MRI scans as follows: 1. Two MRI during 1 day; the second after 30 min interval and a repositioning. 2\. One MRI within one week after the first one. The total scan time will be \~ 1 hour. T1 maps will be calculated after magnetization-prepared 2 rapid acquisition gradient echoes (MP2RAGE6) acquisition based on a product sequence. Magnetization Transfer (MT) sat maps will be calculated. Quantitative susceptibility mapping (QSM) maps will be reconstructed using an in-house implementation of the structural feature based collaborative reconstruction algorithm (SFCR). For the reconstruction of multi-shell diffusion data, AMICO10 Accelerated Microstructure Imaging via Convex Optimization (AMICO) from diffusion MRI data will be used. Myelin Water Fraction maps will be fitted voxel-wise using a Non-Negative Least Squares fitting.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

healthy subjects recruited by public announcements (i.e. advertisement/flyer) on the University Hospital's and the University's notice board

You may qualify if:

• No neurological or psychiatric disorder

You may not qualify if:

• Pregnancy
• Contraindication to MRI (eg, claustrophobia, metallic implants, pacemaker etc).
• Inability to give consent.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Neurologische Klinik und Poliklinik, University Hospital Basel

Basel, 4031, Switzerland

Location

Study Officials

• Cristina Granziera, Prof. Dr. med.

  Neurologische Klinik und Poliklinik, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 17, 2020
• Study Start: February 5, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

CH (1)