Novel MRI Biomarkers for Monitoring Disease Progression in ALS
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|ClinicalTrials.gov Identifier: NCT03362658|
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : January 26, 2023
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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 2023|
|Estimated Study Completion Date :||December 2023|
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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- Patients with a diagnosis of motor neuron disease (MND). This includes the diagnoses of amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA).
- Patients with frontotemporal dementia (FTD) with or without motor neuron signs.
- 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
- 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.
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): NCT03362658
|Contact: Sara Moradipoor, MScfirstname.lastname@example.org|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States|
|Contact: Anna Thompson 305-243-7613 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: Sara Moradipoor, MSc 780-248-1805 email@example.com|
|Canada, British Columbia|
|University of British Columbia / GF Strong Rehab Centre||Withdrawn|
|Vancouver, British Columbia, Canada, V5Z 2G9|
|Western University / London Health Sciences Centre||Withdrawn|
|London, Ontario, Canada, N6A 5A5|
|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 firstname.lastname@example.org|
|Contact: Smita Patel 514-398-1779 email@example.com|
|Quebec City, Quebec, Canada, G1V 0A6|
|Contact: Alexandra Simard, BSc 418-649-0252 ext 63559 firstname.lastname@example.org|
|Principal Investigator:||Sanjay Kalra, MD||FRCPC|
|Responsible Party:||University of Alberta|
|Other Study ID Numbers:||
|First Posted:||December 5, 2017 Key Record Dates|
|Last Update Posted:||January 26, 2023|
|Last Verified:||August 2022|
Magnetic Resonance Imaging
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases