PET Study in Multiple Sclerosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03787446|
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : April 22, 2019
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||9 participants|
|Official Title:||Positron Emission Tomography (PET) Imaging Study in Relapsing-Remitting and Primary-Progressive Multiple Sclerosis (MS): Correlations With Advanced MRI in MS|
|Actual Study Start Date :||March 26, 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||September 2020|
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
- 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.
- Myelin Water Imaging by MRI [ Time Frame: January 2020 ]To quantitatively measure the brain levels of water located within myelin
- Optical Coherence Tomography [ Time Frame: January 2020 ]To correlate brain levels of inflammation measured by 11C-PBR28 with Retinal Nerve Fiber Layer (RNFL) thickness on Optical Coherence Tomography (OCT).
- MS Spectroscopy [ Time Frame: January 2020 ]To correlate brain levels of inflammation and myelin measured by PET with cognitive dysfunction in MS patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787446
|Contact: Janice Jongfirstname.lastname@example.org|
|Contact: Erin Gallingeremail@example.com|
|Canada, British Columbia|
|UBC MS & NMO Clinical Trials Group||Recruiting|
|Vancouver, British Columbia, Canada, V6T1Z3|
|Contact: Janice Jong 604-827-1892 firstname.lastname@example.org|
|Principal Investigator: Robert L Carruthers, MD, FRCPS|
|Principal Investigator:||Robert L Carruthers, MD||MS Clinical Trials Group|