Multimodal imaging outcome measures for ALS (Image ALS)

Brief description of study

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.

Detailed description of study

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).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
ALS,healthy
Age: Between 18 Years - 90 Years
Gender: All

Individuals diagnosed with ALS can participate in the study if:

1. Age > 18 years
2. Enrolled in the CReATe PGB Protocol (where data such as breathing tests, blood tests, and questionnaires will be performed).

3. Able and willing to participate in one-hour Magnetic

Resonance Imaging (MRI) scan at baseline and willing, if able, to participate in the MRI scan at 6- month and 12- month follow-up visits.

4. Clinical diagnosis of ALS by a board-certified neurologist.

5. SVC > 70% at screening visit (breathing test)
6. Less than 3 years since onset of weakness

7. Willing to participate in a 30 minute [18F]-FDG and 1.5 hour

[11C]-PBR28 PET scan within 15 days at baseline and longitudinally at the 3-month and 6-month follow-up visits, if able.

Healthy Controls can participate in the study if:

1. Age > 18 years

2.Enrolled in the CReATe TRIAL READY Protocol (where data such as breathing tests, blood tests, and questionnaires will be performed).

3. Able and willing to participate in one-hour Magnetic Resonance Imaging (MRI) scan at baseline and willing, if able, to participate in the MRI scan at 6-month and 12-month follow-up visits.

4. Self-reported history negative for neurological or psychiatric disease or deemed insignificant by a site PI.

Multimodal imaging outcome measures for ALS (Image ALS)

Brief description of study

Detailed description of study

Eligibility of study

Interested in the study