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

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

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Positron-Emission Tomography
• Intervention / Treatment: Drug: F-18 FEDAA1106 (BAY85-8101); Drug: F-18 FEDAA1106 (BAY85-8101)

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
• Sweden
  • Stockholm, Sweden, 171 76

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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; 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
EXPERIMENTAL: Arm 2	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: December 11, 2009
• First Submitted That Met QC Criteria: December 11, 2009
• First Posted (ESTIMATE): December 14, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 2, 2014
• Last Update Submitted That Met QC Criteria: April 1, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Diagnostic imaging; Multiple sclerosis; Neuroinflammation; PET tracer; PET diagnosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 13101; 2008-000981-22 (EUDRACT_NUMBER)