Multimodal imaging outcome measures for ALS (Image ALS)

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Study Overview

This research study is being done to learn more about changes over time in Positron Emission Tomography/Computed Tomography (PET/CT) imaging in people with amyotrophic lateral sclerosis (ALS).  We need data from people with ALS.
If you agree to be in this study, you will have up to 6 PET/CT scans over 3 study visits within about a 6-month period.  A blood sample will be taken before the scans.  Additional blood samples will be taken during one type of the PET scans.  You must also agree to have 3 MRI scans for this research study which are described in a separate consent form.

Study Description

The purpose of this study is to study a new radioactive tracer, a type of imaging drug that is labeled with a radioactive tag and injected into the body to see how it is taken up in the brain using an imaging procedure called Positron Emission Tomography (PET/CT).  We will use two different kinds of radioactive tracers in this study, 11C-PBR28 and 18F-Fluorodeoxyglucose ([18F]-FDG). We want to know if these radiotracer images can be used in future clinical treatment trials to assess disease progress and how well treatments are working.
 
11C-PBR28 is an investigational or experimental imaging agent that has not yet been approved by the Food and Drug Administration (FDA) for use in humans. The purpose of this study is to test whether 11C-PBR28 binds to a receptor in the brain called a peripheral benzodiazepine receptor (PBR) as a measure of local inflammation and if there are any changes in this binding in repeat scans.
[18F]-FDG is an FDA approved tracer for imaging of the brain and body. We will use the [18F]-FDG uptake as a measure of how sugar is taken up and metabolized in areas of the brain and compare these images to the 11C-PBR28 images.
 
The scans you receive for this research study will not be used for clinical care. This means that your doctors will not use the PET/CT information from this study for your medical care.

You will also be asked to undergo brain MRI scans for this study and will sign a separate consent for the MRI. PET/CT and MRI images will be compared to evaluate changes in the brain over time. You must be in the MRI part of this study to take part in the PET/CT scans for the study.  If you have questions about the MRIs please ask the research staff.
 
The 11C-PBR28 and[18F]- FDG PET/CT scans will be done on the same day as the baseline and 6-month MRI imaging session. You will be asked to undergo an additional 3-month PET/CT imaging session during the study.
There will be one group of patients in this study that will include patients with amyotrophic lateral sclerosis (ALS).

  • Study Identifier: 834366

Recruitment Status

Open

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