Multiple SclerosisPLAQ-MSNCT04126772
Multimodal Imaging of MS Reveals the Smoldering Inflammation
An observational study of Multiple Sclerosis, run by Turku University Hospital at 1 site in Finland.
Trial summary
To evaluate active MS plaque evolution with conventional MRI, QSM-post processing, TSPO-PET imaging and P2X7-PET imaging. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 27 Feb 2019to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will recruit MS patients with active disease and at least 0,5 cm diameter gadolinium enhancing lesion who are followed-up at the Neurology Outpatient Clinic at the Turku University Hospital. The study will not interfere with the initiation or dosage of medication in any manner. For comparison the study will also recruit healthy subjects and secondary progressive MS-patients.
Who may be able to join
- Active MS-patients:
- Informed consent form
- At least one 0,5 cm diameter active gadolinium enhancing lesion detected lately
- Diagnosed MS-disease according to McDonald criteria
- SPMS patients
- Informed consent form
Show all 12Show fewer
- Diagnosed MS-disease according to McDonald criteria
- SPMS disease
- Healthy controls:
- Informed consent form
- healthy
- age and sex matched with MS-patients in RRMS and SPMS groups
Who cannot join
- MS-patients:
- Patients suffering from another brain disease or other autoimmune disease in addition to multiple sclerosis
- Steroid treatment 4 weeks prior to the scan
- Significant pathology in the MRI scan other than MS-related lesions
- Patients suffering from claustrophobia or panic disorder, or patients who have exhibited hypersensitivity of PET markers (practical obstacle to the scan)
- Exposure to experimental radioactivity in the last 12 months such that the dosimetry threshold would be exceeded due to participation in the study
Show all 13Show fewer
- Age over 70
- Healthy controls:
- autoimmune disease, CNS disease or other serious disease
- Steroid treatment 4 weeks prior to the scan or other regular medication
- persons suffering from claustrophobia or panic disorder, or persons who have exhibited hypersensitivity of PET markers (practical obstacle to the scan)
- Exposure to experimental radioactivity in the last 12 months such that the dosimetry threshold would be exceeded due to participation in the study
- Age over 70
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate active MS plaque evolution with conventional MRI, QSM-post processing, TSPO-PET imaging and P2X7-PET imaging.
Read the detailed description
Objective: To establish the QSM-MRI-method as a part of MS-patient research protocol in TPC and to quantify the time and space dependent correlation of QSM-MRI signal and PET-imaging signal with both 11C-PK11195 and 11C-SMW139 radioligands in the brain of MS-patients with active disease, secondary progressive MS-patients and healthy controls.
Background: In MS brain the inflammatory lesions change over time from active to chronic active and finally to chronic inactive plaques. Conventional MRI-imaging is used to detect the lesions but it is not able to differentiate the plaque types. The most acute lesions with blood-brain-barrier defect can be identified using conventional MRI and gadolinium enhancing, but follow-up of the later plaque development with microglial activation at plaque edge is not possible using MRI. Furthermore, the diffuse microglial activation in the NAWM is not detectable with conventional MRI.
In previous studies it has been shown that chronic active plaques have a rim of active microglial cells around them. With QSM-MRI method it is possible to detect and quantify these iron containing active microglia cells around the chronic active plaque. Active microglial cells can also be detected with PET imaging and TSPO-binding radioligand 11C-PK11195 or P2X7 binding radioligand 11C-SMW139. The investigators expect that the microglial activation signals detected with QSM-MRI and PET are co-localized and that these methods would help to differentiate the plaque types and to evaluate the MS plaque evolution.
Study population: 10 MS-patients with acute gadolinium enhancing ≥0,5cm diameter lesion will be imaged at baseline and 4 and 18 months after that. For comparison 10 secondary progressive patients and 20 healthy controls will be imaged at baseline.
Methods: Clinical evaluation, brain QSM-MRI and PET imaging with 11C-PK11195 radiotracer will be performed at baseline, 4 months and 18 months. PET imaging with 11C-CSMW139 radiotracer will be performed at 4 months and 18 months.
For healthy controls, brain QSM-MRI, PET imaging with 11C-PK11195 radiotracer and PET imaging with 11C-SMW139 radiotracer will be performed at baseline. For 12 healthy controls a test-retest imaging with 11C-SMW139 radiotracer will be performed.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active MS patients | 10 MS patients with an active lesion of 0,5 cm diameter | |
| Healthy controls | 20 healthy controls | |
| SPMS patients | 10 SPMS patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
11C-PK11195 binding in MS patient brain
Change in microglia-activity in MS patients during 18 months as measured by [11C]PK11195 PET imaging
Measured: Baseline, 4 months 18 months
11C-SMW139 binding in MS patient brain
Change in microglia-activity in MS patients during 18 months as measured by [11C]SMW139 PET imaging
Measured: Baseline, 4 months 18 months
QSM-signal in MS patient brain
Change in microglia-activity in MS patients during 18 months as measured by QSM-MRI
Measured: Baseline, 4 months 18 months
Secondary outcomes (8)
11C-PK11195 binding in healthy control brain
Change in microglia-activity in healthy controls during 18 months as measured by PET imaging and [11C]PK11195
Measured: Baseline
11C-SMW139 binding in healthy control brain
Change in microglia-activity in healthy controls during 18 months as measured by PET imaging [11C]SMW139
Measured: Baseline
QSM-signal in healthy control brain
Change in microglia-activity in healthy controls during 18 months as measured by QSM-MRI
Measured: Baseline
MRI metrics
To evaluate lesion load of the white matter MS plaques
Measured: Baseline, 4 months, 18 months
EDSS
Expanded Disability Status Scale. The scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Measured: Baseline, 4 months, 18 months
MSFC
Multiple Sclerosis Composite Score which consists of three assessments of walking speed, processing speed and finger dexterity. The scores are combined to provide a Z-score. Lower scores represent greater abnormality.
Measured: Baseline, 4 months, 18 months
Fatigue severity scale
Fatigue Severity Scale is a self-reported, 9-item fatigue scale. Participants rate all 9 items on a 7-point Likert scale (1-2-3-4-5-6-7) depending on how appropriate they felt the statement applied to them over the preceding week. The total score is calculated by adding up the answer from each item and divide by 9. Lower scores indicate better outcomes. Maximum score is 7.
Measured: Baseline, 4 months, 18 months
Modified Fatigue Impact Scale
The Modified Fatigue Impact Scale is a self-report survey that contains 21 items. Each item is rated 0-4. Higher scores indicate a greater impact of fatigue on a person's activities.
Measured: Baseline, 4 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start27 Feb 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Laura Airas, MD,professor, Principal investigator, Turku University Hospital, division of clinical neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126772
- Sponsor's protocol ID
- PLAQ-MS
- Acronym
- PLAQ-MS
- Status last verified
- Jan 2025
- First submitted
- 5 Aug 2019
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sjoros T, Saraste M, Matilainen M, Nylund M, Koivumaki M, Kuhle J, Leppert D, Airas L. Serum glial fibrillary acid protein associates with TSPO-expressing lesions in multiple sclerosis brain. Ther Adv Neurol Disord. 2025 Jul 28;18:17562864251352998. doi: 10.1177/17562864251352998. eCollection 2025.
PubMed 40756531
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Imaging of MS Reveals the Smoldering Inflammation
- ClinicalTrials.gov ID
- NCT04126772
- Acronym / sponsor ID
- PLAQ-MS / PLAQ-MS
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Oct 2019 (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.
To evaluate active MS plaque evolution with conventional MRI, QSM-post processing, TSPO-PET imaging and P2X7-PET imaging.
Detailed description
Objective: To establish the QSM-MRI-method as a part of MS-patient research protocol in TPC and to quantify the time and space dependent correlation of QSM-MRI signal and PET-imaging signal with both 11C-PK11195 and 11C-SMW139 radioligands in the brain of MS-patients with active disease, secondary progressive MS-patients and healthy controls.
Background: In MS brain the inflammatory lesions change over time from active to chronic active and finally to chronic inactive plaques. Conventional MRI-imaging is used to detect the lesions but it is not able to differentiate the plaque types. The most acute lesions with blood-brain-barrier defect can be identified using conventional MRI and gadolinium enhancing, but follow-up of the later plaque development with microglial activation at plaque edge is not possible using MRI. Furthermore, the diffuse microglial activation in the NAWM is not detectable with conventional MRI.
In previous studies it has been shown that chronic active plaques have a rim of active microglial cells around them. With QSM-MRI method it is possible to detect and quantify these iron containing active microglia cells around the chronic active plaque. Active microglial cells can also be detected with PET imaging and TSPO-binding radioligand 11C-PK11195 or P2X7 binding radioligand 11C-SMW139. The investigators expect that the microglial activation signals detected with QSM-MRI and PET are co-localized and that these methods would help to differentiate the plaque types and to evaluate the MS plaque evolution.
Study population: 10 MS-patients with acute gadolinium enhancing ≥0,5cm diameter lesion will be imaged at baseline and 4 and 18 months after that. For comparison 10 secondary progressive patients and 20 healthy controls will be imaged at baseline.
Methods: Clinical evaluation, brain QSM-MRI and PET imaging with 11C-PK11195 radiotracer will be performed at baseline, 4 months and 18 months. PET imaging with 11C-CSMW139 radiotracer will be performed at 4 months and 18 months.
For healthy controls, brain QSM-MRI, PET imaging with 11C-PK11195 radiotracer and PET imaging with 11C-SMW139 radiotracer will be performed at baseline. For 12 healthy controls a test-retest imaging with 11C-SMW139 radiotracer will be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active MS patients | – | –10 MS patients with an active lesion of 0,5 cm diameter |
| Healthy controls | – | –20 healthy controls |
| SPMS patients | – | –10 SPMS patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit MS patients with active disease and at least 0,5 cm diameter gadolinium enhancing lesion who are followed-up at the Neurology Outpatient Clinic at the Turku University Hospital. The study will not interfere with the initiation or dosage of medication in any manner. For comparison the study will also recruit healthy subjects and secondary progressive MS-patients.
Key inclusion criteria (12 listed)
- Informed consent form
- At least one 0,5 cm diameter active gadolinium enhancing lesion detected lately
- Diagnosed MS-disease according to McDonald criteria
- SPMS patients
- Informed consent form
Key exclusion criteria (13 listed)
- Patients suffering from another brain disease or other autoimmune disease in addition to multiple sclerosis
- Steroid treatment 4 weeks prior to the scan
- Significant pathology in the MRI scan other than MS-related lesions
- Patients suffering from claustrophobia or panic disorder, or patients who have exhibited hypersensitivity of PET markers (practical obstacle to the scan)
- Exposure to experimental radioactivity in the last 12 months such that the dosimetry threshold would be exceeded due to participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
11C-PK11195 binding in MS patient brain
Time frame: Baseline, 4 months 18 months
Change in microglia-activity in MS patients during 18 months as measured by [11C]PK11195 PET imaging
11C-SMW139 binding in MS patient brain
Time frame: Baseline, 4 months 18 months
Change in microglia-activity in MS patients during 18 months as measured by [11C]SMW139 PET imaging
QSM-signal in MS patient brain
Time frame: Baseline, 4 months 18 months
Change in microglia-activity in MS patients during 18 months as measured by QSM-MRI
8 secondary outcomes
11C-PK11195 binding in healthy control brain
Time frame: Baseline
11C-SMW139 binding in healthy control brain
Time frame: Baseline
QSM-signal in healthy control brain
Time frame: Baseline
MRI metrics
Time frame: Baseline, 4 months, 18 months
EDSS
Time frame: Baseline, 4 months, 18 months
MSFC
Time frame: Baseline, 4 months, 18 months
Fatigue severity scale
Time frame: Baseline, 4 months, 18 months
Modified Fatigue Impact Scale
Time frame: Baseline, 4 months, 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Derived from this study: PubMed 40756531Sjoros T, Saraste M, Matilainen M, Nylund M, Koivumaki M, Kuhle J, Leppert D, Airas L. Serum glial fibrillary acid protein associates with TSPO-expressing lesions in multiple sclerosis brain. Ther Adv Neurol Disord. 2025 Jul 28;18:17562864251352998. doi: 10.1177/17562864251352998. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
Laura Airas, MD,professor principal investigator
Turku University Hospital, division of clinical neurosciences
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, 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 12 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
11C-PK11195 binding in MS patient brain (time frame: Baseline, 4 months 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04126772, which also lists 1 linked publication.
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 Jan 2025.