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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01031199

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Positron-Emission Tomography Multiple Sclerosis	Drug: F-18 FEDAA1106 (BAY85-8101) Drug: F-18 FEDAA1106 (BAY85-8101)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: F-18 FEDAA1106 (BAY85-8101)

MS/CIS patients: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET

Experimental: Arm 2

Drug: F-18 FEDAA1106 (BAY85-8101)

Healthy controls: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET

Outcome Measures

Primary Outcome 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]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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