Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924
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
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Fluoride
What it measured
Main measures
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
Other measures (4)
Standard Safety Parameter: Adverse Event Collection
maximum time from Screening to Follow-up are 37days
SafetyStandard Safety Parameter: Electrocardiogram
maximum time from Screening to Follow-up are 37days
SafetyStandard Safety Parameter: Safety laboratory
maximum time from Screening to Follow-up are 37days
SafetyStandard Safety Parameter: Vital signs
maximum time from Screening to Follow-up are 37days
Safety
Who could take part
Early (CIS/RIS) · 20 to 55
Show the full criteria
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
Exclusion criteria
Exclusion criteria for all healthy volunteers and patients: * Pregnancy or lactation * Any disease, condition, or concomitant medications that significantly compromises the function of the body systems and could result in excessive accumulation, impaired metabolism, altered excretion of the radiotracer, or might interfere with the conduct of the study or interpretation of the results * other forms of diseases with neuroinflammatory components
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers
Papers
Loading reviews and guidelines…
History
Started
Jan 2009
Main results due
Dec 2009
Finished
Dec 2009