Multiple Sclerosis, Positron-Emission Tomography
Conditions
Keywords
Multiple sclerosis, Diagnostic imaging, Neuroinflammation, PET diagnosis, PET tracer
Brief summary
PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers
Interventions
MS/CIS patients: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer \< 5 µg, PET
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers for brain imaging: * males or females, age 20 - 55 years * assessment of the brain MRI as normal (age-appropriate) * absence of any sign of CNS disease, no co-medi cation Patients for brain imaging * males or females, age 20 - 55 years * patients with previously diagnosed MS, presenting with acute relapse, without any current immunomodulating therapy for MS (drug-naïve), or patients presenting with first clinical episode suggestive of demyelinating disease (Clinically Isolated Syndrome, CIS) * patients with previously diagnosed MS, presenting with acute relapse, receiving currently immunomodulatory therapy exclusively with interferon β * MRI: \>/= 2 T2 lesions and \>/= 1 Gadolinium- (Gd-) enhancing lesion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standard quantification variables derived from 3D PET imaging and brain modeling. | Day of study tracer administration |
| Visual analysis/description of the uptake and description of brain PET scans. | Day of study tracer administration |
Secondary
| Measure | Time frame |
|---|---|
| Standard Safety Parameter: Adverse Event Collection | maximum time from Screening to Follow-up are 37days |
| Standard Safety Parameter: Electrocardiogram | maximum time from Screening to Follow-up are 37days |
| Standard Safety Parameter: Safety laboratory | maximum time from Screening to Follow-up are 37days |
| Standard Safety Parameter: Vital signs | maximum time from Screening to Follow-up are 37days |
Countries
Australia, Sweden
Outcome results
None listed