Novel MRI Biomarkers for Monitoring Disease Progression in ALS
|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: NCT03362658|
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : May 7, 2019
Routine MRI is normal in motor neuron diseases such as ALS. However, advanced MRI techniques can provide an objective measure of degeneration (a "biomarker") by examining brain structure, wiring, chemistry, and function. We will develop and evaluate novel MRI techniques that could improve our understanding of ALS and provide a means to diagnose it sooner and monitor its progression. Importantly, we expect these techniques to improve how new drugs are tested, which may lead to the more rapid discovery of a treatment for ALS.
Each participant will have 3 MRI scans over a period of 8 months, along with neurological and cognitive evaluations. Study visits will take 2 - 3 hours. MRI is a safe technique that does not involve radiation.
|Condition or disease|
|Amyotrophic Lateral Sclerosis Motor Neuron Disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|Official Title:||Novel MRI Biomarkers for Monitoring Disease Progression in ALS|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
ALS patients (as well as patients with other related disorders such PLS, PMA, and ALS-FTD) will be recruited from ALS clinics under the direction of neurologists who are participating in this study. ALS patients should meet research criteria for suspected, possible, probable, probable laboratory supported, or definite ALS.
Healthy controls who are age and gender matched to patients.
- Change in cortical thickness in millimetres. [ Time Frame: 8 months ]This primary analysis will evaluate neuronal integrity at baseline and specified follow up periods. Patients and controls scans will be compared.
- Change in DTI indices (unitless). [ Time Frame: 8 months ]This primary analysis will evaluate white matter integrity at baseline and specified follow up periods. Patients and controls scans will be compared.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362658
|Contact: Dennell M Mah, BAemail@example.com|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States|
|Contact: Jessica Stark 305-243-7613 firstname.lastname@example.org|
|Contact: Ashley Manso email@example.com|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84108|
|Contact: Robert Welsh firstname.lastname@example.org|
|University of Calgary / Heritage Medical Research Clinic||Recruiting|
|Calgary, Alberta, Canada, T2N 4Z6|
|Contact: Victoria Hodgkinson 403-210-7303 email@example.com|
|Contact: Janet Petrillo 403-210-7006 firstname.lastname@example.org|
|University of Alberta||Recruiting|
|Edmonton, Alberta, Canada, T6G 2B7|
|Contact: Dennell Mah, BA 780-248-1805 email@example.com|
|Canada, British Columbia|
|University of British Columbia / GF Strong Rehab Centre||Not yet recruiting|
|Vancouver, British Columbia, Canada, V5Z 2G9|
|Contact: Marife Fabros, RN 604-737-6319 firstname.lastname@example.org|
|Western University / London Health Sciences Centre||Recruiting|
|London, Ontario, Canada, N6A 5A5|
|Contact: Christine Piechowicz 519-685-8500 ext 34858 Christine.Piechowicz@lhsc.on.ca|
|University of Toronto / Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Shirley Pham 416-480-5618 Shirley.Pham@sunnybrook.ca|
|McGill University / Montreal Neurological Institute and Hospital||Recruiting|
|Montreal, Quebec, Canada, H3A 2B4|
|Contact: Natalie Saunders 514-398-6526 email@example.com|
|Contact: Kristiana Salmon 514-398-1779 firstname.lastname@example.org|
|Quebec City, Quebec, Canada, G1V 0A6|
|Contact: Alexandra Simard, BSc 418-649-0252 ext 63559 email@example.com|
|Principal Investigator:||Sanjay Kalra, MD||FRCPC|