Myelin IntegrityNCT04673734
Scan-rescan Reproducibility of Myelin Sensitive MRI Techniques
An observational study of Myelin Integrity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Myelin Integrity
- What is being tested?
- myelin sensitive MRI scan
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Feb 2021to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy subjects recruited by public announcements (i.e. advertisement/flyer) on the University Hospital's and the University's notice board
Who may be able to join
- No neurological or psychiatric disorder
Who cannot join
- Pregnancy
- Contraindication to MRI (eg, claustrophobia, metallic implants, pacemaker etc).
- Inability to give consent.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Neurologische Klinik und Poliklinik, University Hospital Basel
Basel, 4031
About this study
This study is to assess the variation in the measurements of myelin sensitive MRI techniques in both white and grey matter in the brain.
Read the detailed 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.
- Conditions
- Myelin Integrity
- Being tested
- myelin sensitive MRI scan
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myelin sensitive MRI scanDiagnostic 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.
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour total scan time (during a time period of max. 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start5 Feb 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelin IntegrityStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Cristina Granziera, Prof. Dr. med., Principal investigator, Neurologische Klinik und Poliklinik, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673734
- Sponsor's protocol ID
- 2020-02826; me20Granziera3
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2020
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scan-rescan Reproducibility of Myelin Sensitive MRI Techniques
- ClinicalTrials.gov ID
- NCT04673734
- Acronym / sponsor ID
- 2020-02826; me20Granziera3
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess the variation in the measurements of myelin sensitive MRI techniques in both white and grey matter in the brain.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy subjects recruited by public announcements (i.e. advertisement/flyer) on the University Hospital's and the University's notice board
Key inclusion criteria (1 listed)
- No neurological or psychiatric disorder
Key exclusion criteria (3 listed)
- Pregnancy
- Contraindication to MRI (eg, claustrophobia, metallic implants, pacemaker etc).
- Inability to give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myelin sensitive MRI scanAcquisition 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. | Diagnostic test | – |
Primary outcome
analysis of variance between MTI, SBI, MWI, T1 relaxometry and multi-shell diffusion obtained in each subject in each of the 3 scan sessions
Time frame: 1 hour total scan time (during a time period of max. 1 week)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Granziera, Prof. Dr. med. principal investigator
Neurologische Klinik und Poliklinik, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelin Integrity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analysis of variance between MTI, SBI, MWI, T1 relaxometry and multi-shell diffusion obtained in each subject in each of the 3 scan sessions (time frame: 1 hour total scan time (during a time period of max. 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.