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PET Imaging Evaluation of [11C]SY08

Primary Purpose

Parkinson's Disease (PD), Multiple System Atrophy (MSA), Dementia With Lewy Bodies (DLB) and Healthy Controls

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
C11-SY08
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease (PD), Multiple System Atrophy (MSA), Dementia With Lewy Bodies (DLB) and Healthy Controls

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: General Inclusion criteria, all subjects must: Age 50-80 Be able to provide written informed consent or assent Be able to read, speak and understand English (We do not have the resources necessary to properly study non-English speaking patients in this study, given that translation and validation of the assessment tools would be necessary) Be willing and able to participate in one PET/MRI scanning session Additional Inclusion criteria for PD patients, subjects must: Have an existing diagnosis of idiopathic PD, using consensus criteria Stable medications for at least 30 days Hoehn and Yahr stage I-IV A study partner who can answer questions pertaining to daily functioning Additional Inclusion criteria for MSA patients, subjects must: Have an existing diagnosis of MSA, using consensus criteria Stable medications for at least 30 days MSAp or MSAc A study partner who can answer questions pertaining to daily functioning Additional Inclusion criteria for DLB patients, subjects must: Have an existing diagnosis of probable DLB, using consensus criteria Stable medications for at least 30 days Clinical Dementia Rating Scale (CDR) < 0.5 A study partner who can answer questions pertaining to daily functioning Exclusion Criteria: General Exclusion Criteria (All Subjects) History of vascular risk factors (e.g. hypertension, hyperlipidemia), if not well-controlled Major psychiatric disease (e.g.schizophrenia) History of stroke Focal brain lesions on MRI scans History of other major illnesses including, but not limited to, major kidney or liver problems or significant neurological illness Recent surgery that is deemed major by our reviewing physician or nurse practitioner within the past 6 months History of head trauma (as defined as having any insults to the brain that may have resulted from an external mechanical force, such as rapid acceleration or deceleration, impact, blast waves, or penetration by a projectile) Impaired elimination (as defined as having problems with urination) unless being managed Past or present diagnosis of bipolar disorder or other Axis I diagnosis, (treated depression is allowed) Any present substance abuse including drug/alcohol abuse Inability to lie flat on camera bed for up to 90 min Pregnancy or breastfeeding Metallic foreign bodies that would be affected by the MRI magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits (50 milliSieverts) General MR and PET safety exclusion criteria listed below Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, steel implants, ferromagnetic objects such as jewelry or metal clips in clothing Electrical implants such as cardiac pacemakers or perfusion pumps Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest Is unable to lie comfortably on a bed inside a PET camera with their head in the field of view for 60 to 90 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis) Pregnancy: A negative serum pregnancy test is required on the day of the PET procedure in women of child bearing potential Body weight of > 300 lbs (weight limit of the MRI table) Breast feeding mothers Exclusion Criteria for Subjects Undergoing Blood Draws Through an Arterial Line During PET Scan An abnormal result on the modified Allen's test on both hands Raynaud syndrome Bleeding disorder Use of anticoagulants such as Coumadin, Plavix or Lovenox An allergy to Lidocaine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    evaluation of alpha synuclein aggregates in the brain

    Arm Description

    Outcomes

    Primary Outcome Measures

    brain uptake evaluation
    We will use SUV or SUV to evaluate brain uptake

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06098612
    Brief Title
    PET Imaging Evaluation of [11C]SY08
    Official Title
    PET Imaging Evaluation of [11C]SY08
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    November 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The overall goal of the proposed research is to evaluate the use of [11C]SY08 as a PET radiotracer for aggregated alpha synuclein (αS) in individuals with Parkinson's disease (PD), Multiple system atrophy (MSA), Dementia with Lewy Bodies (DLB) and healthy controls. The purpose of this study is to evaluate the use of [11C]SY08 as a PET radiotracer for αS fibrils in individuals with PD, MSA, DLB and healthy controls. The specific aims of the current study are: To determine brain uptake, distribution, and kinetics of [11C]SY08 in healthy individuals. To determine brain uptake, distribution, and kinetics of [11C]SY08 in patients with alpha synuclein aggregates in the brain, including PD, DLB and MSA. To determine human dosimetry of [11C]SY08 in healthy individuals An intravenous bolus injection of [11C]SY08 will be administered per subject for brain PET imaging.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease (PD), Multiple System Atrophy (MSA), Dementia With Lewy Bodies (DLB) and Healthy Controls

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    evaluation of alpha synuclein aggregates in the brain
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    C11-SY08
    Intervention Description
    a PET imaging agent
    Primary Outcome Measure Information:
    Title
    brain uptake evaluation
    Description
    We will use SUV or SUV to evaluate brain uptake
    Time Frame
    up tp 120 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: General Inclusion criteria, all subjects must: Age 50-80 Be able to provide written informed consent or assent Be able to read, speak and understand English (We do not have the resources necessary to properly study non-English speaking patients in this study, given that translation and validation of the assessment tools would be necessary) Be willing and able to participate in one PET/MRI scanning session Additional Inclusion criteria for PD patients, subjects must: Have an existing diagnosis of idiopathic PD, using consensus criteria Stable medications for at least 30 days Hoehn and Yahr stage I-IV A study partner who can answer questions pertaining to daily functioning Additional Inclusion criteria for MSA patients, subjects must: Have an existing diagnosis of MSA, using consensus criteria Stable medications for at least 30 days MSAp or MSAc A study partner who can answer questions pertaining to daily functioning Additional Inclusion criteria for DLB patients, subjects must: Have an existing diagnosis of probable DLB, using consensus criteria Stable medications for at least 30 days Clinical Dementia Rating Scale (CDR) < 0.5 A study partner who can answer questions pertaining to daily functioning Exclusion Criteria: General Exclusion Criteria (All Subjects) History of vascular risk factors (e.g. hypertension, hyperlipidemia), if not well-controlled Major psychiatric disease (e.g.schizophrenia) History of stroke Focal brain lesions on MRI scans History of other major illnesses including, but not limited to, major kidney or liver problems or significant neurological illness Recent surgery that is deemed major by our reviewing physician or nurse practitioner within the past 6 months History of head trauma (as defined as having any insults to the brain that may have resulted from an external mechanical force, such as rapid acceleration or deceleration, impact, blast waves, or penetration by a projectile) Impaired elimination (as defined as having problems with urination) unless being managed Past or present diagnosis of bipolar disorder or other Axis I diagnosis, (treated depression is allowed) Any present substance abuse including drug/alcohol abuse Inability to lie flat on camera bed for up to 90 min Pregnancy or breastfeeding Metallic foreign bodies that would be affected by the MRI magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits (50 milliSieverts) General MR and PET safety exclusion criteria listed below Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, steel implants, ferromagnetic objects such as jewelry or metal clips in clothing Electrical implants such as cardiac pacemakers or perfusion pumps Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest Is unable to lie comfortably on a bed inside a PET camera with their head in the field of view for 60 to 90 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis) Pregnancy: A negative serum pregnancy test is required on the day of the PET procedure in women of child bearing potential Body weight of > 300 lbs (weight limit of the MRI table) Breast feeding mothers Exclusion Criteria for Subjects Undergoing Blood Draws Through an Arterial Line During PET Scan An abnormal result on the modified Allen's test on both hands Raynaud syndrome Bleeding disorder Use of anticoagulants such as Coumadin, Plavix or Lovenox An allergy to Lidocaine
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Changning Wang, PhD
    Phone
    6177243983
    Email
    cwang15@mgh.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    PET Imaging Evaluation of [11C]SY08

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