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Novel MRI Biomarkers for Monitoring Disease Progression in ALS
NCT03362658 · University of Alberta
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
Current clinical measures of disease burden have suboptimal sensitivity to disease progression in ALS. A biomarker would play an essential role in the evaluation of novel therapeutics, leading to the realization of effective treatments faster. Magnetic resonance imaging (MRI) holds promise as a non-invasive source of biomarkers in ALS. In this study data is collected from a national imaging platform (the Canadian ALS Neuroimaging Consortium \[CALSNIC\]) using standardized MRI and clinical protocols.
CALSNIC was founded with the objective to validate MRI biomarkers on a standardized multi-centre platform. CALSNIC is a multidisciplinary group of scientists at 7 centres across Canada. The first CALSNIC study entitled "MRI Biomarkers in ALS" (CALSNIC-1) is ongoing and slated to finish recruitment in 2017.
This study ("Novel MRI Biomarkers for Monitoring Disease Progression in ALS", CALSNIC-2) is a new project that will evaluate novel MRI biomarkers using advanced imaging acquisition and processing methods. The specific aims of CALSNIC-2 are 1) to establish a standardized MRI and clinical protocol across the 7 centres, and 2) to validate MRI measures with clinical measures of disease burden and progression.
It is anticipated that the project will lead to the discovery of MR-based biomarkers of cerebral degeneration that can be applied across different centres and hence, can assist with drug development. Secondly, this project will expand CALSNIC to include more centres and provide opportunities for collaborative and multidisciplinary translational research on a national scale.
Eligibility criteria
Inclusion Criteria:
* Patients with a suspected or confirmed diagnosis as described in Study Populations
* For those with a diagnosis of ALS, patients will be considered with an El Escorial classification of suspected, possible, probable, probable lab-supported, and definite ALS.
* Patients 18 years of age or older
* Healthy controls over the age of 40.
* Be able to lie in an MRI machine for approximately 60 minutes
Exclusion Criteria:
* Subjects with psychiatric/CNS illnesses such as Major Depressive Disorder, Schizophrenia, and Bipolar disorder.
* Subjects with significant head injury or other neurological disease (stroke, brain tumour).
* Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign body.
Study design
Enrollment target: 700 participants
Age groups: adult, older_adult
Timeline
Starts: 2016-10
Estimated completion: 2025-12-31
Last updated: 2025-02-28
Primary outcomes
- • Change in cortical thickness in millimetres. (8 months)
- • Change in DTI indices (unitless). (8 months)
Sponsor
University of Alberta · other
With: University of Calgary, Western University, Canada, McGill University, University of Toronto, University of British Columbia, Laval University, University of Miami, University of Utah
Contacts & investigators
ContactSara Moradipoor, MSc · contact · moradipo@ualberta.ca · 780-248-1805
InvestigatorSanjay Kalra, MD · principal_investigator, FRCPC
All locations (9)
University of MiamiRecruiting
Miami, Florida, United States
University of UtahRecruiting
Salt Lake City, Utah, United States
University of Calgary / Heritage Medical Research ClinicRecruiting
Calgary, Alberta, Canada
University of AlbertaRecruiting
Edmonton, Alberta, Canada
University of British Columbia / GF Strong Rehab CentreWithdrawn
Vancouver, British Columbia, Canada
Western University / London Health Sciences CentreWithdrawn
London, Ontario, Canada
University of Toronto / Sunnybrook Health Sciences CentreRecruiting
Toronto, Ontario, Canada
McGill University / Montreal Neurological Institute and HospitalRecruiting
Montreal, Quebec, Canada
Laval UniversityRecruiting
Québec, Quebec, Canada