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

Primary Purpose

Positron-Emission Tomography, Multiple Sclerosis

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

F-18 FEDAA1106 (BAY85-8101)

About this trial

This is an interventional diagnostic trial for Positron-Emission Tomography focused on measuring Multiple sclerosis, Diagnostic imaging, Neuroinflammation, PET diagnosis, PET tracer

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Standard quantification variables derived from 3D PET imaging and brain modeling.

Visual analysis/description of the uptake and description of brain PET scans.

Secondary Outcome Measures

Standard Safety Parameter: Adverse Event Collection

Standard Safety Parameter: Electrocardiogram

Standard Safety Parameter: Safety laboratory

Standard Safety Parameter: Vital signs

Full Information

NCT ID

NCT01031199

First Posted

December 11, 2009

Last Updated

April 1, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01031199

Brief Title

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

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Positron-Emission Tomography, Multiple Sclerosis

Keywords

Multiple sclerosis, Diagnostic imaging, Neuroinflammation, PET diagnosis, PET tracer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

F-18 FEDAA1106 (BAY85-8101)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

F-18 FEDAA1106 (BAY85-8101)

Intervention Description

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

Primary Outcome Measure Information:

Title

Standard quantification variables derived from 3D PET imaging and brain modeling.

Time Frame

Day of study tracer administration

Title

Visual analysis/description of the uptake and description of brain PET scans.

Time Frame

Day of study tracer administration

Secondary Outcome Measure Information:

Title

Standard Safety Parameter: Adverse Event Collection

Time Frame

maximum time from Screening to Follow-up are 37days

Title

Standard Safety Parameter: Electrocardiogram

Time Frame

maximum time from Screening to Follow-up are 37days

Title

Standard Safety Parameter: Safety laboratory

Time Frame

maximum time from Screening to Follow-up are 37days

Title

Standard Safety Parameter: Vital signs

Time Frame

maximum time from Screening to Follow-up are 37days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

55 Years

Accepts 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

23618062

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.

Results Reference

derived

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

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