NCT06098612 PET Imaging Evaluation of [11C]SY08
| NCT ID | NCT06098612 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Massachusetts General Hospital |
| Condition | Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2024-05-01 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: 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.
Eligibility Criteria
Inclusion Criteria: * General Inclusion criteria, all subjects must: 1. Age 50-80 2. Be able to provide written informed consent 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: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06098612 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06098612 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06098612 currently recruiting?
Yes, NCT06098612 is actively recruiting participants. Contact the research team at cwang15@mgh.harvard.edu for enrollment information.
Where is the NCT06098612 trial being conducted?
This trial is being conducted at Charlestown, United States.
Who is sponsoring the NCT06098612 clinical trial?
NCT06098612 is sponsored by Massachusetts General Hospital. The trial plans to enroll 40 participants.
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