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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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ClinicalTrials.gov Identifier: NCT01031199
Recruitment Status : Completed
First Posted : December 14, 2009
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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) Phase 1

Study Type : Interventional  (Clinical Trial)
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 : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Standard quantification variables derived from 3D PET imaging and brain modeling. [ Time Frame: Day of study tracer administration ]
  2. Visual analysis/description of the uptake and description of brain PET scans. [ Time Frame: Day of study tracer administration ]

Secondary Outcome Measures :
  1. Standard Safety Parameter: Adverse Event Collection [ Time Frame: maximum time from Screening to Follow-up are 37days ]
  2. Standard Safety Parameter: Electrocardiogram [ Time Frame: maximum time from Screening to Follow-up are 37days ]
  3. Standard Safety Parameter: Safety laboratory [ Time Frame: maximum time from Screening to Follow-up are 37days ]
  4. Standard Safety Parameter: Vital signs [ Time Frame: maximum time from Screening to Follow-up are 37days ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031199


Locations
Australia, Victoria
Heidelberg, Victoria, Australia, 3084
Sweden
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01031199     History of Changes
Other Study ID Numbers: 13101
2008-000981-22 ( EudraCT Number )
First Posted: December 14, 2009    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: April 2014

Keywords provided by Bayer:
Multiple sclerosis
Diagnostic imaging
Neuroinflammation
PET diagnosis
PET tracer

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases