Scan-rescan Reproducibility of Myelin Sensitive MRI Techniques

Myelin Integrity Clinical Trial

Official title:

Scan-rescan Reproducibility of Myelin Sensitive MRI Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673734
• Other study ID #: 2020-02826; me20Granziera3
• Status: Completed
• Start date: February 5, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Magnetization Transfer Imaging (MTI) permits the assessment of the integrity of macromolecules in brain tissue, such as myelin and cellular/axonal membrane components.

Multi-echo Susceptibility-Based imaging (SBI) provides quantitative susceptibility maps and T2* maps that - when combined - permit the disentanglement of myelin from iron and various phases of myelin degradation.

Myelin Water Imaging (MWI) quantifies the water trapped between myelin layers by separating the multiple water components in T2 relaxometry data. In fact, the presence of myelin on water pools bound to it provokes a loss in magnetic resonance (MR)-signal coherence, which is more rapid than the one characterizing the water pools located within the axons or in the cytoplasm.

A method based on a spiral acquisition that achieves a myelin-specific signal in clinically compatible scan times is currently applied: T1 relaxometry (quantitative T1, qT1) - which measures the time that a perturbed nuclear spin distribution needs to get back to equilibrium in the longitudinal plane- is sensitive to a number of components of the brain tissue such as myelin, axonal diameter and the overall architectural organization of the brain tissue.

Finally, multi-shell diffusion allows the application of mathematical models of diffusion compartments, which in part are influenced by myelin integrity.

The goal of this study is to assess the stability of these techniques in scan-rescan experiment on 20 healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• No neurological or psychiatric disorder

Exclusion Criteria:

• Pregnancy

• Contraindication to MRI (eg, claustrophobia, metallic implants, pacemaker etc).

• Inability to give consent.

Related Conditions & MeSH terms

• Hypersensitivity
• Myelin Integrity

Intervention

Diagnostic Test:
• myelin sensitive MRI scan
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.

Locations

Country	Name	City	State
Switzerland	Neurologische Klinik und Poliklinik, University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Hoffmann-La Roche

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)