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Imaging activated microglia in relapsing remitting multiple sclerosis: a first in human P2X7r PET study

Imaging activated microglia in relapsing remitting multiple sclerosis: a first in human P2X7r PET study - M1MS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47369
Enrollment
20
Registered
2018-03-21
Start date
2017-05-30
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple sclerosis

Interventions

Microglia
Multiple Sclerosis
Positron Emission Tomography (PET)

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - For the MS patient group: diagnosis of relapsing remitting MS with clinically or radiologically active disease - 20 to 60 years old - Written informed consent

Exclusion criteria

Exclusion criteria: - Current or recent immunomodulating or immunosuppressive therapy, excluding first-line MS treatment started less than 3 months prior to the PET-scans. - Inability to undergo MRI and PET scan (metal objects in or around the body, claustrophobia or inability to lie still in the scanner) and for the patient group contra-indication for gadolinium administration - Significant immune disease other than MS - (History of) other relevant neurological disease - Known allergy including, but not limited to, hay fever, dust mite allergy and allergies to cats or dogs - Known asthma - History of malignancy - Known significant cardiac disease - Inadequate renal function: creatinine clearance

Design outcomes

Primary

MeasureTime frame
- To determine whether binding of the P2X7-receptor radioligand [11C]SMW139 in the brain in vivo can discriminate active RRMS patients from healthy controls. - To assess retest variability in regional [11C]SMW139 brain uptake - To evaluate which tracer kinetic method is the most suitable for quantification of [11C]SMW139 binding.

Secondary

MeasureTime frame
- To determine whether [11C]SMW139 binding is increased in T2 hyperintense lesions and T1 gadolinium enhancing on MRI. - To determine whether [11C]SMW139 binding correlates with clinical disability in clinically and/or radiologically active RRMS patients.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)