Correlation Between PET and Advanced MRI in Multiple Sclerosis

October 2, 2019 updated by: Philippe Beauchemin, University of British Columbia

Pilot Study of Positron Emission Tomography (PET) Imaging: Correlations With Advanced Magnetic Resonance Imaging in Multiple Sclerosis

Traditional Magnetic Resonance Imaging (MRI) in Multiple Sclerosis (MS) has enabled clinicians to measure disease activity but there are inherent limitations. Clinical/radiographic dissociation can be seen in some patients and the abnormalities are not specific.

This pilot study is an opportunity to determine the relationship between quantitative advanced MRI measures and OCT with PET measurements of microglial activation and myelin health.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • MS Clinical Trials Group - UBC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

4 untreated RRMS, 4 untreated SPMS, 4 untreated PPMS patients, 4 healthy controls and 4 GA 40mg TIW

Description

Inclusion Criteria:

  • Diagnosed with Multiple Sclerosis according to the 2011 McDonald criteria.
  • Aged 18 to 60
  • High or mixed affinity binder to rs6971 TSPO polymorphism

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Suffering from an unstable medical condition
  • Have a neurological or ocular disorder other than MS
  • Any contra-indications to MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Multiple Sclerosis (MS) patients
4 Secondary Progressive MS patients on no disease modifying therapy 4 Primary Progressive MS patients on no disease modifying therapy 4 Relapsing-Remitting MS patients on no disease modifying therapy 4 Relapsing-Remitting MS patients on Glatiramer Acetate 40 mg three times a week
Healthy Controls
4 Healthy volunteers aged between 18-60 years of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Whole Brain PBR28 binding
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Lesional PiB binding
Time Frame: Baseline
Baseline
Myelin Water Imaging
Time Frame: Baseline
Baseline
MR Spectroscopy (Total NAA, NAA/Cr, mI)
Time Frame: Baseline
Baseline
Optical Coherence Tomography (RNFL thickness)
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Teva Pharmaceuticals USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

October 2, 2019

Study Completion (Actual)

October 2, 2019

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNS-2016-293

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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