Multiple SclerosisROMUSNCT02403570
Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Turku University Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
- What is being tested?
- Brain MRI
- How many people
- 21 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2015to 31 Dec 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Finland1 site
Division of Clinical Neurosciences, Turku University Hospital
Turku, FI-20520
About this study
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.
- Conditions
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
- Being tested
- Brain MRI
- Keywords
- Multiple Sclerosis, MRI, rotating frame
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis | Brain MRI using advanced MR techniques Receives: Other: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MR relaxation values 0
Aim is to measure different quantitative MR relaxation values (e.g. Traff, T1rho) in different brain areas of patients with MS at baseline
Measured: Baseline
MR relaxation values 1
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
Measured: One year
Secondary outcomes (2)
MR relaxation values and clinical markers 0
Aim is to study the correlation between MR relaxation values and clinical markers of MS at baseline
Measured: Baseline
MR relaxation values and clinical markers 1
Aim is to study the correlation between MR relaxation values and clinical markers of MS after one year follow up
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hannu Aronen, Turku University Hospital
- Investigators
- Hannu Aronen, M.D., Ph.D., Principal investigator, Turku University Hospital, Department of Diagnostic Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403570
- Sponsor's protocol ID
- T125/2014
- Acronym
- ROMUS
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2015
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02403570
- Acronym / sponsor ID
- ROMUS / T125/2014
- Conditions
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
- Keywords
- Multiple Sclerosis, MRI, rotating frame
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Feb 2015
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 31 Mar 2015 (estimated)
- 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis | – | Other: Brain MRIBrain MRI using advanced MR techniques |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Brain MRI | Other | Multiple Sclerosis |
Primary outcome
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
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
2 secondary outcomes
MR relaxation values and clinical markers 0
Time frame: Baseline
MR relaxation values and clinical markers 1
Time frame: One year
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 3 Mar 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.
Hannu Aronen, M.D., Ph.D. principal investigator
Turku University Hospital, Department of Diagnostic Radiology
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 Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Turku University Hospital at 1 site in Finland.
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 4 inclusion and 6 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 3 Mar 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 Finland. 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?
MR relaxation values 0 (time frame: Baseline). The study lists 2 primary outcomes in all. 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 3 Mar 2021.