Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06032026
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2023-07-25
Brief Title:
Study of Biodistribution Metabolism Excretion and Brain Uptake of 11C-HY-2-15
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Center Without Walls for Imaging Proteinopathies With PET CW2IP2 Phase I Pilot Study of Biodistribution Metabolism Excretion and Brain Uptake of 11C-HY-2-15
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current protocol is to determine the biodistribution metabolism excretion and brain uptake of 11C HY-2-15 The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Multiple System Atrophy MSA The investigators will compare uptake in people with MSA with people with Parkinson disease PD and progressive supranuclear palsy PSP as well as healthy volunteers This multicenter project funded by an NIH U19 grant is centered at U Pennsylvania Penn Grant PI Robert Mach in collaboration with U Pittsburgh Pitt not a clinical site Yale U U of California at San Francisco UCSF and Washington University in St Louis WU The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites
Detailed Description:
The current protocol is to determine the biodistribution metabolism excretion and brain uptake of 11C HY-2-15 The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Multiple System Atrophy MSA The investigators will compare uptake in people with MSA with people with Parkinson disease PD and progressive supranuclear palsy PSP as well as healthy volunteers This multicenter project funded by an NIH U19 grant is centered at U Pennsylvania Penn Grant PI Robert Mach in collaboration with U Pittsburgh Pitt not a clinical site Yale U U of California at San Francisco UCSF and Washington University in St Louis WU The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites
At all participating clinical sites will recruit 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 The investigators will encourage equal participation of males and females
This protocol will include up to 70 participants across all clinical sites note that at least 10 of these participant scans from Penn may be used to calculate whole body biodistribution BioD and dosimetry The investigators anticipate enrollment of up to 20-25 participants at each clinical site who will undergo up to approximately 120 minutes of dynamic brain PET scanning with or without torso imaging depending on the clinical site the scan time may be shortened at the discretion of an investigator and subjects may also be given breaks during the scan session if necessary for subject tolerance A second IV or an arterial line may be placed in the arm contralateral to the side of injection for blood metabolite analysis andor 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 may undergo a research brain MRI that may or may not be on a separate day from the PET this may not be repeated if participants have a brain MRI deemed adequate by a study investigator for the purposes of this study
PET imaging sessions will include an injection of 20 mCi approximate range for most studies is anticipated to be 8 - 20 mCi at sites with a standard PET scanner or 3 - 20 at sites with a high sensitivity scanner of 11C HY-2-15 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 HY-2-15 in the disease cohorts and healthy controls The safety of 11C HY-2-15 will also be evaluated in all participants
At all participating clinical sites will recruit 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 The investigators will encourage equal participation of males and females
This protocol will include up to 70 participants across all clinical sites note that at least 10 of these participant scans from Penn may be used to calculate whole body biodistribution BioD and dosimetry The investigators anticipate enrollment of up to 20-25 participants at each clinical site who will undergo up to approximately 120 minutes of dynamic brain PET scanning with or without torso imaging depending on the clinical site the scan time may be shortened at the discretion of an investigator and subjects may also be given breaks during the scan session if necessary for subject tolerance A second IV or an arterial line may be placed in the arm contralateral to the side of injection for blood metabolite analysis andor 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 may undergo a research brain MRI that may or may not be on a separate day from the PET this may not be repeated if participants have a brain MRI deemed adequate by a study investigator for the purposes of this study
PET imaging sessions will include an injection of 20 mCi approximate range for most studies is anticipated to be 8 - 20 mCi at sites with a standard PET scanner or 3 - 20 at sites with a high sensitivity scanner of 11C HY-2-15 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 HY-2-15 in the disease cohorts and healthy controls The safety of 11C HY-2-15 will also be evaluated in all participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None