Clinical trial NCT01031199: Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Positron-Emission Tomography
Multiple Sclerosis
Keywords: Multiple sclerosis
Diagnostic imaging
Neuroinflammation
PET diagnosis
PET tracer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-12-14
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers


Eligibility 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

Primary outcomes:
measure: Standard quantification variables derived from 3D PET imaging and brain modeling.
timeFrame: Day of study tracer administration
measure: Visual analysis/description of the uptake and description of brain PET scans.
timeFrame: Day of study tracer administration
Secondary outcomes:
measure: Standard Safety Parameter: Adverse Event Collection
timeFrame: maximum time from Screening to Follow-up are 37days
measure: Standard Safety Parameter: Electrocardiogram
timeFrame: maximum time from Screening to Follow-up are 37days
measure: Standard Safety Parameter: Safety laboratory
timeFrame: maximum time from Screening to Follow-up are 37days
measure: Standard Safety Parameter: Vital signs
timeFrame: maximum time from Screening to Follow-up are 37days
Other outcomes:
Locations:
city: Heidelberg
country: Australia
state: Victoria
city: Stockholm
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Takano A, Piehl F, Hillert J, Varrone A, Nag S, Gulyas B, Stenkrona P, Villemagne VL, Rowe CC, Macdonell R, Tawil NA, Kucinski T, Zimmermann T, Schultze-Mosgau M, Thiele A, Hoffmann A, Halldin C. In vivo TSPO imaging in patients with multiple sclerosis: a brain PET study with [18F]FEDAA1106. EJNMMI Res. 2013 Apr 24;3(1):30. doi: 10.1186/2191-219X-3-30.