Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis (TRACK-ALS)
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|ClinicalTrials.gov Identifier: NCT02559869|
Recruitment Status : Active, not recruiting
First Posted : September 24, 2015
Last Update Posted : February 20, 2020
|Condition or disease||Intervention/treatment|
|Amyotrophic Lateral Sclerosis (ALS)||Drug: [18F] GE-180|
In this trial, approximately 200 subjects will participate in this study from 2 Northeast ALS Consortium (NEALS) centers in the United States. Fifty (50) ALS participants will be age and gender matched to 50 participants with no known neurological disorder (healthy controls). Of these, twenty five (25) ALS participants will be age (±5 years) gender and binding affinity (TSPO) matched to 25 healthy controls.
During the enrollment period 200 participants will be screened and 100 participants will ultimately be scanned. There will be a maximum allowed time of 45 days between the screening and baseline visits (1st scan). All 100 subjects will undergo MRI scanning and clinical assessment at the Baseline Visit. Healthy control participants will have no further follow-up visits once they have completed their participation in the screening and baseline visits. Only 50 subjects from this sample will undergo PET scanning. The ALS participants will return for follow-up MRI scanning and clinical assessments every three months and follow-up PET scanning every 6 months over a 12-month period.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||May 2021|
Amyotrophic Lateral Sclerosis (ALS)
Subjects will be diagnosed with possible, probable, probable-lab supported, or definite ALS.
Drug: [18F] GE-180
PET Tracer Ligand
Subjects with no known neurological disorder.
Drug: [18F] GE-180
PET Tracer Ligand
- Measure & localize brain inflammation in people with ALS via [18F] GE-180 PET imaging. [ Time Frame: 12 months ]Aim 1 will be accomplished by obtaining [18F] GE-180 PET imaging from 25 people with ALS compared to 25 age, gender, and binding affinity matched healthy volunteers.
- Define anatomical, structural, and functional changes in the brain via MRI of ALS Subjects vs. Healthy Controls at Baseline [ Time Frame: 12 months ]Aim 1 will be accomplished by obtaining state of-the-art MRI acquisition sequences from 50 people with ALS compared to 50 MRI age- and gender-matched healthy volunteers.
- Determine systemic inflammatory factors that may modify the progression or other clinical or imaging correlates of ALS. [ Time Frame: 12 months ]Blood from 100 subjects will be studied to quantitate circulating pro- and anti-inflammatory monocyte/macrophage and T cells, with results to be correlated with neuroimaging and evaluated as potential biomarkers of disease progression.
- Determine the longitudinal changes in brain inflammation in people with ALS in correlation with ALS severity and rate of progression. [ Time Frame: 12 months ]Clinical and [18F] GE-180 PET imaging data will be collected every 6 months from the 25 people with ALS for at least 12 months.
- Determine the longitudinal changes in the anatomical, structural, and functional measures in people with ALS, and build ALS prediction models using the clinical and MRI data. [ Time Frame: 12 months ]Clinical and MRI data will be collected every 3 months from 50 people with ALS for at least 12 months.
Biospecimen Retention: Samples With DNA
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): NCT02559869
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Texas|
|Houston Methodist Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Suma Babu, MD||Massachusetts General Hospital|
|Principal Investigator:||Joseph Masdeu, MD, PhD||Houston Methodist Neurological Institute|