Positron Emission Tomography (PET) Imaging Study in Relapsing-Remitting and Primary-Progressive Multiple Sclerosis (MS): Correlations With Advanced MRI in MS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- University of British Columbia
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Whole Brain PBR28 binding
- Last Updated
- 7 years ago
Overview
Brief Summary
While both conventional and advanced MRI techniques offer important insights into MS pathophysiology, important aspects of this inflammatory disorder are undetectable with existing MRI technology. In Multiple Sclerosis (MS), there is growing interest in PET as an imaging modality that can increase the investigator's understanding of the disease processes and may add to an understanding of MS phenotype, particularly when combined with advanced MRI techniques such as myelin water imaging.
Detailed Description
This is an exploratory study. PBR28 PET scan is new, promising and exploratory endpoints in MS clinical trials, making sample size estimation difficult. A separate pre-screening consent form will be issued for the TSPO rs6971 polymorphism and eGFR blood samples, a separate pre-screening step. Eligible participants, according to their TSPO rs6971 polymorphism will be presented a separate study consent form to continue into the clinical trial. Study Assessments include 1 PET scan, 1 MRI scan, OCT, EDSS exam, physical exam, cognitive questionnaires, etc.
Investigators
Robert Carruthers
Principal Investigator
University of British Columbia
Eligibility Criteria
Inclusion Criteria
- •Subjects diagnosed with Multiple Sclerosis according to the 2010 McDonald criteria or otherwise in the opinion of the investigator (including relapsing-remitting and primary-progressive).
- •Aged 18 to 60 years.
- •Mixed affinity binder according to rs6971 TSPO polymorphism
- •Creatinine clearance over 60 mL/min\*). \* Blood result valid up to 3 months prior to the MRI scan.
Exclusion Criteria
- •Low and high affinity binders according to rs6971 TSPO polymorphism
- •Subject pregnant or breastfeeding.
- •Subjects with a Body Mass Index (BMI) \>35kg/m³.
- •Hospitalization within 1 month of screening visit.
- •Medical history or current heart failure
- •Medical history or current pulmonary failure
- •Current or Historical Drug or alcohol abuse in the opinion of the investigator.
- •Regular use of anti-inflammatory agents (more than once a week use of aspirin, NSAIDS, Steroids, immunomodulating drugs), unless patient is able to washout from anti-inflammatory drugs 2 weeks prior to PBR PET scan.
- •Neurological disorder other than MS, including Brain Trauma, stroke, Parkinson disease, Alzheimer disease, encephalitis.
- •Subjects with a history of radiation treatment or other high amounts of radiation exposure in the opinion of the investigator.
Outcomes
Primary Outcomes
Whole Brain PBR28 binding
Time Frame: January 2020
To show an increase in 11C-PBR28 binding in all sub-types of MS compared to healthy controls.
Secondary Outcomes
- Myelin Water Imaging by MRI(January 2020)
- Optical Coherence Tomography(January 2020)
- MS Spectroscopy(January 2020)