PET Imaging Evaluation of [11C]SY08

Launched by MASSACHUSETTS GENERAL HOSPITAL · Oct 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging tool called [11C]SY08, which helps doctors see a specific protein in the brain called alpha synuclein. This protein is linked to conditions like Parkinson's disease, Multiple System Atrophy, and Dementia with Lewy Bodies. The goal is to understand how well this imaging tool works in different groups, including healthy individuals and those with these diseases. By using a special scan called a PET scan, researchers will look at how the [11C]SY08 moves and behaves in the brain.

To participate, individuals need to be between 50 and 80 years old, able to speak and understand English, and provide consent. People with a diagnosis of Parkinson’s, Multiple System Atrophy, or Dementia with Lewy Bodies can join, provided they have been stable on their medications for at least 30 days. Participants will receive an injection of [11C]SY08 and then undergo a PET scan. It's important to note that there are specific health criteria that may prevent someone from joining, such as certain medical conditions or recent surgeries. If you or someone you know is interested in learning more about this study, it could be a chance to contribute to important research in understanding these neurological conditions.

Gender

ALL

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