Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy Volunteers

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

Official Title
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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

Conditions
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Positron-Emission Tomography, Multiple Sclerosis

Intervention / Treatment
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* Drug: F-18 FEDAA1106 (BAY85-8101)
* Drug: F-18 FEDAA1106 (BAY85-8101)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: F-18 FEDAA1106 (BAY85-8101)<br>* MS/CIS patients: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET<br>|
| Experimental: Arm 2<br> | Drug: F-18 FEDAA1106 (BAY85-8101)<br>* Healthy controls: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, Diagnostic imaging, Neuroinflammation, PET diagnosis, PET tracer