NCT06098612 · Massachusetts General Hospital
PET Imaging Evaluation of [11C]SY08
What this study is about
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.
View original scientific description
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: 1. To determine brain uptake, distribution, and kinetics of \[11C\]SY08 in healthy individuals. 2. To determine brain uptake, distribution, and kinetics of \[11C\]SY08 in patients with alpha synuclein aggregates in the brain, including PD, DLB and MSA. 3. 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.
Interventions
DRUG
C11-SY08
a PET imaging agent
Primary outcome measures
brain uptake evaluation
Time frame: up tp 120 minutes
The investigators will use SUV or SUV to evaluate brain uptake
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- General Inclusion criteria, all subjects must:
- Be able to provide written informed consent or assent
- Be able to read, speak and understand English (The investigators 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
Where
- Charlestown, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 24, 2025 · Source of record for eligibility and locations