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Positron Emission Tomography to Characterize in vivo Neuroinflammation in the Spinal Cord in People with ALS

Study Purpose:

This study is being conducted to learn more about inflammation in the spinal cord and brain of people with ALS. Inflammation is being assessed using simultaneous magnetic resonance imaging (MRI) and positron emission tomography (PET).

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Healthy Volunteer

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging

Study Status:

Not enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Suma Babu, MD, Massachusetts General Hospital

Clinicaltrials.gov ID (11 digit #):

Not Applicable

Neals Affiliated?

No

Coordinating Center Contact Information

Massachusetts General Hospital
Austin Lewis / .(JavaScript must be enabled to view this email address) / 617-724-7928
Mackenzie Keegan / .(JavaScript must be enabled to view this email address) / 617-643-6252
165 Cambridge Street
Suite 600
Boston, Massachusetts 02114 United States

Full Study Summary:

Massachusetts General Hospital is seeking individuals to participate in a brain and spinal cord imaging research study enrolling under the direction of Suma Babu, MD. This study is being done to learn more about changes in the spinal cord and brain in ALS. “Microglia” are a type of immune cell that we are particularly interested in. We would like to find out if microglia are activated in the spinal cord and brain of individuals with ALS. Special imaging techniques are now available to test for changes in microglia. Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) are two tests that allow us to take pictures and “look inside” the body without surgery. MR-PET scanners use both MRI and PET tests at the same time. The MR-PET scanner may give clearer images and more information about the inside of the body. If you choose to take part in this study you may have 5 visits at MGH, up to 3 months apart. We will pay you $150 for completion of the spinal cord MR-PET scan. If you choose to participate in the optional brain MR-PET scan you will be paid an additional $50 for completion.

Study Sponsor:

ALS Finding a Cure

Participant Duration:

2 visits over 3 months

Estimated Enrollment:

Estimated Study Start Date:

11/23/2016

Estimated Study Completion Date:

05/16/2017

Posting Last Modified Date:

02/08/2021

Date Study Added to alsconsortium.org:

12/08/2016
  • More Information

    What participants may be asked to do

    Simultaneous magnetic resonance imaging (MRI) and positron emission tomography (PET)

    Study activities may include:

    • Blood draw
    • Injection or IV
    • MRI Scan
    • PET Scan

    What participants may get

    Participants will be reimbursed for parking and up to $200 for completing all imaging components.

    For more information, please visit https://clinicaltrials.partners.org/study/10104

  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    Participants should be 18-80 years old, safe to undergo MRI (no magnetic or electrically powered implants), and able to comfortably lay flat for over an hour.

  • Site Contact Information

    Massachusetts General Hospital
    165 Cambridge Street
    Boston, Massachusetts 02114
    United States