Sphingosine-1 Phosphate -Receptor Targeting and Microglial Activation

NCT02139696 | Completed

• 1 other identifier: FINGOPET
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change of 11C-PK11195-radioligand binding using PET

  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.

  0 to 24 weeks

Secondary Outcomes (1)

• MRI metrics

  0, 6-8 wk, 24 wk

Study Arms (1)

MS patients initiating fingolimod

Patients will be imaged using PET and MRI at baseline, and twice during treatment.

Radiation: PET and MRI

Interventions

PET and MRI RADIATION

Patients will be imaged using PET and MRI at baseline, and twice during treatment

MS patients initiating fingolimod

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

Related Publications (1)

• Rissanen E, Tuisku J, Rokka J, Paavilainen T, Parkkola R, Rinne JO, Airas L. In Vivo Detection of Diffuse Inflammation in Secondary Progressive Multiple Sclerosis Using PET Imaging and the Radioligand (1)(1)C-PK11195. J Nucl Med. 2014 Jun;55(6):939-44. doi: 10.2967/jnumed.113.131698. Epub 2014 Apr 7.

  PMID: 24711650 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Laura Airas, MD, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 15, 2014
• Study Start: September 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: October 1, 2016
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

FI (1)