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Completed

NCT Number: NCT01031199

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

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

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Heidelberg, Victoria, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

F-18 FEDAA1106 (BAY85-8101)

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 14, 2009
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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