F-18 FEDAA1106 (BAY85-8101)
DrugMS/CIS patients: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET
NCT Number: NCT01031199
PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers
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Notify Me20 year–55 year
All sexes
Interventional
Phase 1
Heidelberg, Victoria, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Healthy volunteers for brain imaging:
Exclusion criteria
Exclusion criteria
for all healthy volunteers and patients:
MS/CIS patients: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET
Time frame: Day of study tracer administration
Time frame: Day of study tracer administration
Time frame: maximum time from Screening to Follow-up are 37days
Time frame: maximum time from Screening to Follow-up are 37days
Time frame: maximum time from Screening to Follow-up are 37days
Time frame: maximum time from Screening to Follow-up are 37days
Bayer
Industry
Open-label, Non-randomized, Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 140 MBq (ca. 5 mSv) ZK 6032924 (BAY85-8101) for Its Diagnostic Potential in Either Drug-naïve or Specifically (IFN-beta) Pretreated Patients With Multiple Sclerosis (MS) With Acute Relapse or Patients With Clinically Isolated Syndrome (CIS), Compared to Healthy Volunteers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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