Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503
NCT ID: NCT06303921
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
70 participants
INTERVENTIONAL
2024-02-16
2029-02-28
Brief Summary
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Detailed Description
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Participating clinical sites will recruit up to 20 people with PD, 20 with MSA, 10 with PSP and 20 healthy controls across sites with all participants ranging from 40-85 years old. Investigators will encourage equal participation of males and females.
This protocol will include up to 70 participants across all clinical sites (note that some of these participant scans performed at Penn may be used to calculate whole body biodistribution (BioD) and dosimetry. Investigators anticipate enrollment of up to 15-20 participants at each clinical site, who will undergo up to 120 minutes of dynamic brain PET scanning (with or without torso imaging, depending on the clinical site). A second IV or an arterial line may be placed, preferably in the arm contralateral to the side of injection, for blood metabolite analysis and/or radioactive counts at various times during the scanning session. These blood draw collections can be omitted at the discretion of the investigator. For participants at Penn that may be part of BioD analysis, urine may be collected at the end of the scan session. Participants will also undergo a research brain MRI that may be on a separate day from the PET.
PET imaging sessions will include an injection of ≤ 15 mCi (approximate range for most studies is anticipated to be 8 - 15 mCi at sites with a standard PET scanner or 3 - 15 at sites with a high sensitivity scanner) of 11C-M503. Biodistribution, metabolism, excretion and pilot brain uptake data will be collected and human dosimetry will be calculated from participants scanned at Penn who have whole body scans. PET scans will be collected to evaluate image quality and collect preliminary information on brain uptake of 11C-M503 in the disease cohorts and healthy controls. The safety of 11C-M503 will also be evaluated in all participants. Some participants (usually those with positive 11C-M503 PET scan) may also be asked to have an amyloid-beta (Aβ) PET scan to investigate specificity of 11C-M503.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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11C-M503 PET
Participants will undergo 11C-M503 PET scan, they may also have a brain MRI and Amyloid PET scan as well as neurological assessments.
11C-M503 PET
2 hour Positron Emission Tomography (PET) scan using new radiotracer 11C-M503
Brain MRI
MRI scan of brain.
Amyloid PET
PET scan with Florbetaben F18 or 11C-PiB
Neurological assessments
Neurological assessments, including a video interview.
Interventions
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11C-M503 PET
2 hour Positron Emission Tomography (PET) scan using new radiotracer 11C-M503
Brain MRI
MRI scan of brain.
Amyloid PET
PET scan with Florbetaben F18 or 11C-PiB
Neurological assessments
Neurological assessments, including a video interview.
Eligibility Criteria
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Inclusion Criteria
* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures or Participants who are deemed unable to provide informed consent must have a designated study partner present for consent and to accompany them to study visits
* Investigators will ask PD/MSA/PSP participants to agree to brain donation but this choice is not mandatory for participation in this study.
Exclusion Criteria
* Forms of parkinsonism other than PD, PSP and MSA as defined above
* Major psychiatric disorder (e.g. schizophrenia or bipolar disorder) - major depressive disorder is allowed
* History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
* Contraindications or inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician
* Contraindication to MRI, such as non-compatible implanted medical device
* Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician or investigator to be a condition that could compromise participant safety or successful participation in the study
40 Years
85 Years
ALL
Yes
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Ilya M Nasrallah, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Yale New Haven Hospital
New Haven, Connecticut, United States
Washington University in St. Louis
St Louis, Missouri, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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854681
Identifier Type: -
Identifier Source: org_study_id
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