Multimodal Imaging of MS Reveals the Smoldering Inflammation

NCT04126772 | Active Not Recruiting

• 1 other identifier: PLAQ-MS
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate active MS plaque evolution with conventional MRI, QSM-post processing, TSPO-PET imaging and P2X7-PET imaging.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• 11C-PK11195 binding in MS patient brain

  Change in microglia-activity in MS patients during 18 months as measured by \[11C\]PK11195 PET imaging

  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

  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

  Baseline, 4 months 18 months

Secondary Outcomes (8)

• 11C-PK11195 binding in healthy control brain

  Baseline

• 11C-SMW139 binding in healthy control brain

  Baseline

• QSM-signal in healthy control brain

  Baseline

• MRI metrics

  Baseline, 4 months, 18 months

• EDSS

  Baseline, 4 months, 18 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku PET Centre

Turku, Southwest Finland, 20520, Finland

Location

Related Publications (1)

• 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.

  PMID: 40756531 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and faecal samples

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laura Airas, MD,professor

  Turku University Hospital, division of clinical neurosciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: October 15, 2019
• Study Start: February 27, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

FI (1)