ClinicalTrials.gov record NCT06098612
PET Imaging Evaluation of [11C]SY08
PET Imaging Evaluation of [11C]SY08
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This early-phase interventional study tests [11C]SY08, a PET imaging agent, in people with Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, and healthy controls. Each participant will receive a single intravenous bolus of [11C]SY08 and undergo brain PET (and MRI) imaging. Researchers will measure tracer uptake and distribution in the brain and estimate radiation dosimetry.
What it is studying. The study is testing the use of [11C]SY08 as a PET radiotracer to detect aggregated alpha‑synuclein (αS) fibrils in the human brain. It aims to measure how the tracer is taken up, where it goes in the brain, its kinetics (how it moves and clears), and the radiation dose in healthy people and in people with Parkinson's disease, multiple system atrophy, or dementia with Lewy bodies.
What the researchers hope to learn. Determine brain uptake, distribution, and kinetics of [11C]SY08 in healthy individuals and in patients with alpha‑synucleinopathies (PD, MSA, DLB). Determine human radiation dosimetry of [11C]SY08. Provide early human data on [11C]SY08 as an imaging marker for aggregated alpha‑synuclein.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- C11-SY08
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 (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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants attend one PET/MRI brain scanning visit. They receive an intravenous bolus injection of [11C]SY08 and lie still with their head in the scanner for about 60–120 minutes while imaging is performed. Some participants may have arterial blood draws via an arterial line during the scan (additional eligibility applies). Parkinson's, MSA, and DLB patients should bring a study partner to answer questions about daily functioning; women of childbearing potential will have a pregnancy test on the day of the scan.
How the study is structured. Single-group, open-label interventional (Early Phase 1) study. Participants receive one intravenous bolus of [11C]SY08 and have a brain PET scan combined with MRI; imaging is performed up to about 120 minutes to assess tracer uptake using standardized uptake values (SUV). No masking (non-blinded).
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on multiple system atrophy
Important dates
- Study start
- May 1, 2024
- Primary completion
- November 2026 (estimated)
- Study completion
- November 2027 (estimated)
- Target enrollment
- 40 participants (estimated)
- Last updated on registry
- Dec 24, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Massachusetts General Hospital
- Principal investigator
- Changning Wang, Associate Professor
Massachusetts General Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Changning Wang, PhD 📞 6177243983 ✉ cwang15@mgh.harvard.edu
Participating sites (1)
- MGHRecruiting
Charlestown, Massachusetts, 02129-2020 · United States
- Changning Wang · 617-724-3983 · cwang15@mgh.harvard.edu
Terms used on this page · explanations by MedicalUpdates.ai
- PET
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
- Inclusion criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- assent
- A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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