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Sphingosine-1 Phosphate -Receptor Targeting and Microglial Activation (FINGOPET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139696
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital

Brief Summary:
To evaluate the usability of positron emission tomography imaging as a novel outcome measure in multiple sclerosis studies

Condition or disease Intervention/treatment
Multiple Sclerosis Radiation: PET and MRI

Detailed Description:

Background and Rationale

In multiple sclerosis (MS), significant pathology correlating to disease progression, to expanded disability status scale (EDSS) and to cognitive decline, takes place outside the plaque areas, i.e. in areas of normal appearing white matter and gray matter. Neuropathological studies suggest that mechanisms involved in this widespread pathology include activation of microglial cells, oxidative stress and deficiency in mitochondrial functions. Activated microglia can be detected in vivo with a translocator protein (TSPO), expressed in activated, but not resting microglia) binding radioligands and positron emission tomography (PET). 11Carbon-PK11195 radioligand is one such radioligand. Importantly, the possible effect of MS therapies on microglial activity can be evaluated in patients in vivo with PET-imaging performed before and after the treatment.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Targeting of Sphingosine-1 Phosphate Receptors Reduce Microglial Activation in Multiple Sclerosis? A [11C]PK11195 Brain PET Study
Study Start Date : September 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MS patients initiating fingolimod
Patients will be imaged using PET and MRI at baseline, and twice during treatment.
Radiation: PET and MRI
Patients will be imaged using PET and MRI at baseline, and twice during treatment




Primary Outcome Measures :
  1. Change of 11C-PK11195-radioligand binding using PET [ Time Frame: 0 to 24 weeks ]
    Patients will be switched to fingolimod from first-line therapies as per indication and as part of their normal treatment regimen, and those who will consent to participate in this investigator-initiated PET study, will be imaged at baseline (pre-treatment phase) and after 6-8 weeks and 24 weeks of treatment. Purpose is to compare the binding of the radioligand between these three time points.


Secondary Outcome Measures :
  1. MRI metrics [ Time Frame: 0, 6-8 wk, 24 wk ]
    To evaluate the total lesion load of the white matter MS plaques with MRI; baseline vs. 6-8 weeks vs. 24 weeks of Gilenya treatment



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Ages Eligible for Study:   18 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
10 patients with multiple sclerosis who will be initiated on fingolimod in the neurology outpatient clinic of the Turku University hospital in Turku, Finland.
Criteria

Inclusion Criteria:

Having signed the informed consent of the investigator-initiated PET study

  • Age 18 - 58 years at the time of informed consent.
  • MS according to Poser or McDonald criteria
  • EDSS score from 0.0 to 6.5.
  • Moderate to heavy lesion load ( >9 T2 lesions) in MRI

Exclusion Criteria:

  • - Patients with other neurodegenerative disease than MS
  • Disease modifying therapy (DMT) within 4 weeks of imaging
  • Corticosteroid treatment within 4 weeks of imaging
  • Patients with significant abnormal findings other than MS in the screening MRI.
  • Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
  • Contraindication to PET scan investigations
  • Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study.
  • Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans.

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): NCT02139696


Locations
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Finland
Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Laura Airas, MD, PhD Turku University Hospital
Publications:
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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02139696    
Other Study ID Numbers: FINGOPET
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases