- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02403570
Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis (ROMUS)
March 2, 2021 updated by: Hannu Aronen, Turku University Hospital
The aim of this study is to develop novel magnetic resonance imaging (MRI) protocols suitable for patients with multiple sclerosis using advanced MRI such as rotating frame relaxation imaging.
In addition, the investigators want to study the correlation between advanced MRI parameters and clinical disease progression.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
21
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
-
-
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Turku, Finland, FI-20520
- Division of Clinical Neurosciences, Turku University Hospital
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-
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
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
MS patients with relapsing-remitting or secondary progressive MS will be recruited from amongst the MS patients in the neurological outpatient policlinics in the Hospital District of Southwestern Finland.
Description
Inclusion Criteria:
- The diagnosis of relapsing remitting MS made according to the Poser, McDonald's or revised McDonald's criteria (Group I) before participating in the study
- Initial MS diagnosis of relapsing remitting form of the disease according to the criteria as mentioned above, and conversion into the secondary progressive phase of the disease as evaluated by the referring neurologist according to the clinical evaluation and confirmed by the study physician (Group II).
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
Exclusion Criteria:
- Any other autoimmune disease than MS requiring immunomodulatory or immunosuppressive medication
- High-dose corticosteroid treatment within 30 days before participating in the study
- Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
- Any psychiatric condition that compromises the subject's ability to participate in the study
- Infections: Patient must not have an uncontrolled serious infection
- No contraindications for MRI (cardiac pacemaker, intracranial clips etc)
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 |
---|---|
Multiple Sclerosis
Brain MRI using advanced MR techniques
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MR relaxation values 0
Time Frame: Baseline
|
Aim is to measure different quantitative MR relaxation values (e.g.
Traff, T1rho) in different brain areas of patients with MS at baseline
|
Baseline
|
MR relaxation values 1
Time Frame: One year
|
Aim is to measure different quantitative MR relaxation values (e.g.
Traff, T1rho) in different brain areas of patients with MS after one year follow-up
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MR relaxation values and clinical markers 0
Time Frame: Baseline
|
Aim is to study the correlation between MR relaxation values and clinical markers of MS at baseline
|
Baseline
|
MR relaxation values and clinical markers 1
Time Frame: One year
|
Aim is to study the correlation between MR relaxation values and clinical markers of MS after one year follow up
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hannu Aronen, M.D., Ph.D., Turku University Hospital, Department of Diagnostic Radiology
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
February 1, 2015
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
March 10, 2015
First Submitted That Met QC Criteria
March 25, 2015
First Posted (Estimate)
March 31, 2015
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 2, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Multiple Sclerosis, Chronic Progressive
- Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
Other Study ID Numbers
- T125/2014
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.
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