ClinicalTrials.gg
RecruitingNCT06098612Updated Dec 24, 2025

PET Imaging Evaluation of [11C]SY08

An Early Phase 1 interventional study of C11-SY08 in Parkinson's Disease, Multiple System Atrophy and Dementia With Lewy Bodies, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started May 2024; still recruiting 2 years 6 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
50 Years to 80 Years
Sex
All
01

Study 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:

  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.

02

Conditions studied

  • Parkinson's Disease
  • Multiple System Atrophy
  • Dementia With Lewy Bodies
  • Healthy Controls
03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • General Inclusion criteria, all subjects must:

    1. Age 50-80
    2. Be able to provide written or assent
    3. 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)
    4. Be willing and able to participate in one PET/MRI scanning session

Additional Inclusion criteria for PD patients, subjects must:

  1. Have an existing diagnosis of idiopathic PD, using consensus criteria
  2. Stable medications for at least 30 days
  3. Hoehn and Yahr stage I-IV
  4. A study partner who can answer questions pertaining to daily functioning

Additional Inclusion criteria for MSA patients, subjects must:

  1. Have an existing diagnosis of MSA, using consensus criteria
  2. Stable medications for at least 30 days
  3. MSAp or MSAc
  4. A study partner who can answer questions pertaining to daily functioning

Additional Inclusion criteria for DLB patients, subjects must:

  1. Have an existing diagnosis of probable DLB, using consensus criteria
  2. Stable medications for at least 30 days
  3. Clinical Dementia Rating Scale (CDR) \< 0.5
  4. A study partner who can answer questions pertaining to daily functioning

Exclusion criteria

Exclusion Criteria:

  • General Exclusion Criteria (All Subjects)

    1. History of vascular risk factors (e.g. hypertension, hyperlipidemia), if not well-controlled
    2. Major psychiatric disease (e.g.schizophrenia)
    3. History of stroke
    4. Focal brain lesions on MRI scans
    5. History of other major illnesses including, but not limited to, major kidney or liver problems or significant neurological illness
    6. Recent surgery that is deemed major by our reviewing physician or nurse practitioner within the past 6 months
    7. 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)
    8. Impaired elimination (as defined as having problems with urination) unless being managed
    9. Past or present diagnosis of bipolar disorder or other Axis I diagnosis, (treated depression is allowed)
    10. Any present substance abuse including drug/alcohol abuse
    11. Inability to lie flat on camera bed for up to 90 min
    12. Pregnancy or breastfeeding
    13. 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
    14. 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

  1. 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
  2. Electrical implants such as cardiac pacemakers or perfusion pumps
  3. Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
  4. 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)
  5. Pregnancy: A negative serum pregnancy test is required on the day of the PET procedure in women of child bearing potential
  6. Body weight of > 300 lbs (weight limit of the MRI table)
  7. Breast feeding mothers

Exclusion Criteria for Subjects Undergoing Blood Draws Through an Arterial Line During PET Scan

  1. An abnormal result on the modified Allen's test on both hands
  2. Raynaud syndrome
  3. Bleeding disorder
  4. Use of anticoagulants such as Coumadin, Plavix or Lovenox
  5. An allergy to Lidocaine
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    evaluation of alpha synuclein aggregates in the brain

    Drug: C11-SY08

Interventions

  • DrugC11-SY08

    a PET imaging agent

06

What researchers measure

Primary outcomes

  1. brain uptake evaluation

    The investigators will use SUV or SUV to evaluate brain uptake

    Time frame: up tp 120 minutes

07

Study locations

1 of 1 sites recruiting
  • MGH
    Charlestown, Massachusetts 02129-2020, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Nov 2026, 30 months after the start.

Of 77 non-industry phase 1 interventional studies under Parkinson Disease, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 68. This study's planned 30 months is below that.

Counting every sponsor, half of 204 studies reached it within 19 months; a quarter within 5 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2023
First posted
Oct 24, 2023
StartActual
May 1, 2024
Primary completionEst.
Nov 2026
CompletionEst.
Nov 2027
Last update
Dec 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06098612
Responsible party
Changning Wang (Associate Professor, Massachusetts General Hospital) — Principal investigator
First posted
Oct 24, 2023
Start date
May 1, 2024
Primary completion
Nov 2026 (estimated)
Completion
Nov 2027 (estimated)
Last update
Dec 24, 2025

Study contacts

Changning Wang, PhD
Contact
cwang15@mgh.harvard.edu
6177243983

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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