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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 : May 14, 2018
Sponsor:
Collaborators:
University of Calgary
Western University, Canada
McGill University
University of Toronto
University of British Columbia
Laval University
Information provided by (Responsible Party):
Sanjay Kalra, University of Alberta

Brief Summary:

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

Detailed Description:

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
Observational Model: Case-Control
Time Perspective: Prospective
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


Group/Cohort
Patients
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.
Controls
Healthy controls who are age and gender matched to patients.



Primary Outcome Measures :
  1. 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.

  2. 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
Study Population
  1. 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).
  2. Patients with frontotemporal dementia (FTD) with or without motor neuron signs.
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.

Information from the National Library of Medicine

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


Contacts
Contact: Dennell M Mah, BA 780-248-1805 dennell.mah@ualberta.ca
Contact: Brian Steele 780-248-1805 bjsteele@ualberta.ca

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States
Contact: Jessica Stark    305-243-7613    jhs55@med.miami.edu   
Contact: Ashley Manso       a.manso@miami.edu   
Canada, Alberta
University of Calgary / Heritage Medical Research Clinic Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Victoria Hodgkinson    403-210-7303    vhodgkin@ucalgary.ca   
Contact: Janet Petrillo    403-210-7006    japetril@ucalgary.ca   
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Dennell Mah, BA    780-248-1805    dennell.mah@ualberta.ca   
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    marife.fabros@vch.ca   
Canada, Ontario
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   
Contact: Serena Soleimani    416-480-6860 ext 87561    serena.soleimani@sunnybrook.ca   
Canada, Quebec
McGill University / Montreal Neurological Institute and Hospital Recruiting
Montreal, Quebec, Canada, H3A 2B4
Contact: Natalie Saunders    514-398-6526    natalie.saunders@mcgill.ca   
Contact: Kristiana Salmon    514-398-1779    kristiana.salmon@mcgill.ca   
Laval University Recruiting
Quebec City, Quebec, Canada, G1V 0A6
Contact: Alexandra Simard, BSc    418-649-0252 ext 63559    alexandra.simard@crchudequebec.ulaval.ca   
Sponsors and Collaborators
University of Alberta
University of Calgary
Western University, Canada
McGill University
University of Toronto
University of British Columbia
Laval University
Investigators
Principal Investigator: Sanjay Kalra, MD FRCPC

Responsible Party: Sanjay Kalra, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT03362658     History of Changes
Other Study ID Numbers: RES0027887
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Keywords provided by Sanjay Kalra, University of Alberta:
Magnetic Resonance Imaging
MRI
Biomarker

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Disease Progression
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Disease Attributes
Pathologic Processes