Ultra-high-field Brain MRI in Multiple Sclerosis (ULTIMS)

September 13, 2024 updated by: Zuyderland Medisch Centrum

Multiple Sclerosis Lesion Characterization on Ultra-high-field MRI: Comparative Pilot Study of 9.4 Vs 7 Vs 3 Tesla

The MRI scan is one of the most important tools for diagnosing multiple sclerosis (MS) and for monitoring disease progression and medication effects. Increasingly strong MRI magnets (higher field strength) enable us to see abnormalities in the brain in greater detail. On the other hand, it poses challenges because these higher field strength MRIs are more sensitive to disturbances, for example due to motion, including physiological motion such as breathing and swallowing. In current practice, field strengths of up to 3 Tesla are common. The aim of this study is to compare scanning at field strengths of 3 Tesla in 10 MS patients at two different moments (baseline and 6 months) with scanning at field strengths that are higher, namely 7 and 9.4 Tesla, in order to identify the advantages and disadvantages. With the further development of this technique, the investigators may be able to make a better diagnosis in the future and detect subtle changes in the course of the disease more quickly in order to optimize treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Multiple sclerosis (MS) is the most common demyelinating disease of the central nervous system. MRI has a prominent role in diagnosing and monitoring disease and treatment and is most suitable tool to study MS pathology in vivo. In recent years there has been research has been much research on the use of 7 tesla MRI in MS. There is a better signal and contrast allowing for higher resolutions. This may contribute to, among other things, higher sensitivity for detecting MS abnormalities, not only in the white matter but also in the gray matter. Furthermore, there is probably also a better specificity. This is due to the improved visualization of MS specific pathological features such as the presence of a central vein in a lesion and paramagnetic rings.

In this pilot study, the investigators study whether going beyond the field strength of 7 Tesla (7T) has additional benefits in characterizing MS lesions and to also map the limitations and challenges of scanning above 7T. More specifically, first, whether scanning above 7T might improve sensitivity to white and gray matter abnormalities in MS. Second, whether MS specific pathology, such as the central veins and the paramagnetic rings, are better visualized at the higher compared to lower field strengths. To this end, the investigators want to scan 10 relapsing-remitting MS patients for clinical field strength (3T) and also ultra-high field strengths (7T and 9.4T) at two time points (baseline and after 6 months).

If it can demonstrate through this pilot study that scanning at field strengths above 7T can benefit detection of lesions or certain pathological features, the use of this research tool can help us in future studies to better understand MS.

Study Type

Observational

Enrollment (Actual)

10

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

  • Netherlands
    • Limburg
      • Geleen, Limburg, Netherlands, 6162BG
        • Zuyderland MC

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The investigators aim to include 10 patients from our outpatient clinic, with a known clinical diagnosis of relapsing remitting MS according to the 2017 McDonald criteria between ages of 18-65 years, who had a new lesion on their clinical brain MRI in the prior 15 months. The intention is to include patients on low-efficacy medication (interferon β, peginterferon, glatiramer acetate, teriflunomide) as well as patients on high-efficacy medication (natalizumab, ocrelizumab, alemtuzumab, fingolimod) to have a varied and representative study population. The investigators estimate it highly realistic that inclusion of these 10 patients can be achieved.

Description

Inclusion Criteria:

  • Relapsing remitting MS patients (according to the 2017 McDonald criteria)
  • Age 18-65 years
  • New brain MRI lesion in the past 15 months.

Exclusion Criteria:

  • Non-compatible implanted material/devices
  • Not being able to lie flat long enough (for the MRI) because of another medical condition

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MS scan cohort
10 patients with a known clinical diagnosis of relapsing remitting MS according to the 2017 McDonald criteria between ages of 18-65 years, who had a new lesion on their clinical brain MRI in the prior 15 months. The investigators intend to include patients on low-efficacy medication (interferon β, peginterferon, glatiramer acetate, teriflunomide) as well as patients on high-efficacy medication (natalizumab, ocrelizumab, alemtuzumab, fingolimod) to have a varied and representative study population.
Diagnostic test: Brain MRI (3T, 7T, 9.4T)
All patients will undergo anatomical brain imaging on a 3T, 7T and 9.4T MRI scanner within the same day at baseline and again 6 months later. An optimized protocol for every separate field strength will be run. Sequences will include at least T1-weighted, T2*-weighted and a T2 SPACE or FLAIR sequence. No intravenous contrast will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detected white- and grey-matter lesions
Time Frame: 6 months
Given that the present study is a pilot, descriptive statistics will be employed to identify important trends between field strengths, evaluating the number of lesions that can be identified in white as well as grey matter, in what proportion of lesions a perivenous localization can be identified
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Image quality parameters (signal-to-noise and contrast-to-noise ratios)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zuyderland Medisch Centrum

Collaborators

Scannexus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 12, 2023

Primary Completion (Actual)

June 17, 2024

Study Completion (Actual)

June 17, 2024

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 13, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z2022009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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 Multiple Sclerosis

Clinical Trials on Brain MRI (3T, 7T, 9.4T)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe