RECRUITING

PET Imaging Evaluation of [11C]SY08

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

PET Imaging Evaluation of [11C]SY08

Quick Facts

Study Start:2024-05

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06098612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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 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 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	* 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) 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 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

Inclusion Criteria

Exclusion 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
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
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
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

* 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)
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
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

Contacts and Locations

Study Contact

Changning Wang, PhD

CONTACT

6177243983

cwang15@mgh.harvard.edu

Study Locations (Sites)

MGH

Charlestown, Massachusetts, 02129-2020

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05

Study Completion Date2025-11

Study Record Updates

Study Start Date2024-05

Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

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