PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
16
MS/CIS patients: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer \< 5 µg, PET
Healthy controls: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer \< 5 µg, PET
Unnamed facility
Heidelberg, Victoria, Australia
Unnamed facility
Stockholm, Sweden
Standard quantification variables derived from 3D PET imaging and brain modeling.
Time frame: Day of study tracer administration
Visual analysis/description of the uptake and description of brain PET scans.
Time frame: Day of study tracer administration
Standard Safety Parameter: Adverse Event Collection
Time frame: maximum time from Screening to Follow-up are 37days
Standard Safety Parameter: Electrocardiogram
Time frame: maximum time from Screening to Follow-up are 37days
Standard Safety Parameter: Safety laboratory
Time frame: maximum time from Screening to Follow-up are 37days
Standard Safety Parameter: Vital signs
Time frame: maximum time from Screening to Follow-up are 37days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.