PET Imaging Evaluation of [11C]SY08
Massachusetts General Hospital · NCT06098612
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 50–80 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Early Phase 1
- Target enrollment
- 40
- US sites recruiting
- 1
- Study start
- May 1, 2024
- Record last updated
- December 24, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the 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.
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.
Being studied: C11-SY08
Conditions: Parkinson's Disease; Multiple System Atrophy; Dementia With Lewy Bodies; Healthy Controls
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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 (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
Recruiting US locations
MGH
Charlestown, MA 02129-2020
Site contact: Changning Wang · 617-724-3983 · cwang15@mgh.harvard.edu
Study contacts (from the official record)
- Changning Wang, PhD · 6177243983 · cwang15@mgh.harvard.edu
Similar studies in Massachusetts
All neurology studies in Massachusetts →- RecruitingHealthy volunteersPhase 1
Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation
General Biophysics LLC
- Location
- Boston, MA
- Eligibility basics
- Ages 55–75
- RecruitingPhase 1/Phase 2Overnight stay mentioned
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Vector Y Therapeutics
- Location
- Boston, MA + 3 other US sites
- Eligibility basics
- Ages 18+
- RecruitingHealthy volunteersPhase 1
Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects
Massachusetts General Hospital
- Location
- Boston, MA
- Eligibility basics
- Ages 18–65
- RecruitingHealthy volunteersEarly Phase 1
Transcranial Magnetic Stimulation Treatment for Alzheimer's Disease
Massachusetts General Hospital
- Location
- Boston, MA
- Eligibility basics
- Ages 40–99