PET Study in Multiple Sclerosis (NCT03787446) | Clinical Trial Compass
UnknownNot Applicable
PET Study in Multiple Sclerosis
Canada9 participantsStarted 2019-03-26
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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 polymorphism1.
* 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.
* 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…