Does Microglial Activation Promote Lesion Growth and Progression Among Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

— FUP-MS  

Official title:

Does Microglial Activation Promote Lesion Growth and Progression Among Multiple Sclerosis Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04625049
• Other study ID #: FUP-MS
• Status: Enrolling by invitation
• Start date: April 1, 2021
• Est. completion date: November 2031

Study information

• Verified date: April 2024
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess whether increased microglial activation (measured using TSPO-PET) at lesion rim is associated with more rapid lesion growth during 10 year follow up.

Description:

Objective: To evaluate individual MS lesions and their growth during a total of 10 year follow-up after initial positron emission tomography (PET) -imaging with PK11195 or TMSX radioligands.

Background: Focal inflammatory lesions in the white and grey matter of the central nervous system represent the best characterized pathological phenomena of MS disease. Some MS lesions slowly expand over time. Neuropathological studies have detected inflammatory rim formed by activated microglia cells around some MS lesions and it has been suggested that the presence of the inflammatory rim could predict lesion expansion. Our hypothesis is that the lesions with higher TSPO or TMSX radioligand binding at the initial PET scan will expand more during the total of 10-year follow up compared to those lesions with lower radioligand binding. This longitudinal follow-up study will provide a more complete picture of the association of the innate immune cell activation, lesion growth and disease progression.

Study population: The research will recruit approximately 100 MS-patients who have taken part to our previous PET-imaging MS studies in Turku PET centre. The research interventions will consist of magnetic resonance imaging (MRI) scans, blood sampling, clinical neurological evaluation and patient-reported outcome measures (filling forms).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: November 2031
• Est. primary completion date: November 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participation to a previous PET imaging study of Airas group

• MS diagnosis

Exclusion Criteria:

• Patients with other neurodegenerative disease than MS

• Contraindication to MR scan investigations

• Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Finland	Turku PET Centre	Turku	Finland Proper

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of the lesion volume changes to the microglial activity at the initial positron emission tomography imaging	Correlation of the lesion volume changes in the magnetic resonance imaging to the microglial activity at the initial PET imaging	Baseline (initial PET), 3, 5, 7 and 10 years
Secondary	magnetic resonance imaging metrics	To evaluate whole brain, white matter, gray matter volumes during follow-up	Baseline (initial PET), 3, 5, 7 and 10 years
Secondary	Multiple Sclerosis Composite Score	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	Baseline (initial positron emission tomography), 3, 5, 7 and 10 years