PET Study in Multiple Sclerosis
Positron Emission Tomography (PET) Imaging Study in Relapsing-Remitting and Primary-Progressive Multiple Sclerosis (MS): Correlations With Advanced MRI in MS
1 other identifier
observational
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2018
CompletedFirst Posted
Study publicly available on registry
December 26, 2018
CompletedStudy Start
First participant enrolled
March 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedApril 22, 2019
April 1, 2019
11 months
December 19, 2018
April 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Whole Brain PBR28 binding
To show an increase in 11C-PBR28 binding in all sub-types of MS compared to healthy controls.
January 2020
Secondary Outcomes (3)
Myelin Water Imaging by MRI
January 2020
Optical Coherence Tomography
January 2020
MS Spectroscopy
January 2020
Study Arms (2)
Multiple Sclerosis (MS) patients
3 Primary Progressive MS patients on no disease modifying therapy and 3 Relapsing-Remitting MS patients on no disease modifying therapy
Healthy Controls (HC)
3 Healthy volunteers aged between 18-60 years of age
Eligibility Criteria
3 untreated RRMS, 3 untreated PPMS and 3 healthy controls
You may qualify if:
- 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 polymorphism1.
- Creatinine clearance over 60 mL/min\*). \* Blood result valid up to 3 months prior to the MRI scan.
You may not qualify if:
- 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.
- Subjects with a history of metastatic cancer including solid tumors and hematological malignancies, except basal cell, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix or the uterus that have been excised with clear margins.
- Inability to tolerate lying supine for the duration of the MRI and PET scan.
- Claustrophobia.
- Current use of MS drugs as described by the list of prohibited medications.
- Known or suspected piece of metal in eye(s)
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Hoffmann-La Rochecollaborator
Study Sites (1)
UBC MS & NMO Clinical Trials Group
Vancouver, British Columbia, V6T1Z3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert L Carruthers, MD
MS Clinical Trials Group
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 19, 2018
First Posted
December 26, 2018
Study Start
March 26, 2019
Primary Completion
March 1, 2020
Study Completion
September 1, 2020
Last Updated
April 22, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share