Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059046
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-04-16
Brief Title:
Brain Imaging of Serotonin Transporters in the Brain
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Kinetic Studies in Whole Body and Brain of 11CDASB PET Imaging of Serotonin Transporters
Status:
COMPLETED
Status Verified Date:
2005-01
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:
Serotonin is a chemical involved in the regulation of emotions anxiety sleep stress and other body functions The purpose of this study is to use brain imaging technology to study how serotonin works in the brain
The serotonin transporter SERT regulates the release of sertonin throughout the body Until recently radioactive chemicals called tracers were not suitable for viewing SERT activity However a newly developed tracer called 11CDASB can be used with positron emission tomography PET imaging to view the parts of the brain that use serotonin
Participants in this study will be screened with medical and psychiatric examinations an electrocardiogram EKG and blood and urine tests This study comprises two parts During Part 1 participants will undergo a whole-body PET scan During Part 2 participants will undergo a magnetic resonance imaging MRI scan of the brain At the next study visit participants will have one or two PET head scans If not is not possible to perform both scans on the same day an additional visit will be scheduled for the second PET scan
The serotonin transporter SERT regulates the release of sertonin throughout the body Until recently radioactive chemicals called tracers were not suitable for viewing SERT activity However a newly developed tracer called 11CDASB can be used with positron emission tomography PET imaging to view the parts of the brain that use serotonin
Participants in this study will be screened with medical and psychiatric examinations an electrocardiogram EKG and blood and urine tests This study comprises two parts During Part 1 participants will undergo a whole-body PET scan During Part 2 participants will undergo a magnetic resonance imaging MRI scan of the brain At the next study visit participants will have one or two PET head scans If not is not possible to perform both scans on the same day an additional visit will be scheduled for the second PET scan
Detailed Description:
The serotonin transporter SERT modulates the activity of the central serotonergic system and SERT is also the primary target of the widely prescribed specific serotonin reuptake inhibitors Until recently suitable radioligands for in vivo imaging of SERT have not been available However a recently developed PET radioligand 11CDASB appears suitable for quantifying SERT in humans In the two protocols that have been approved by the CSRP for submission to the IRB we planned to use 11CDASB PET to study the pathophysiology of SERT in Parkinsons disease and OCD This protocol was created to address criticisms raised by the NIH RDRC committee and the external scientific review
1 The NIH RDRC Radioactive Drug Research Committee review of this protocol asked that we obtain human biodistribution data to confirm the expected low levels of radiation exposure based upon our prior studies in monkeys
2 To address one of the criticisms raised by the CSRP review namely 1 to quantify SERT binding parameters with 11CDASB in up to 10 normal subjects and 2 to determine the reliability and reproducibility of SERT binding parameter measurements by performing a second retest 11CDASB PET study in the same subjects because such data are not available for this radioligand PET scanning will be performed with an intravenous injection of 20 mCi of 11CDASB for 2 h during which multiple arterial blood samples will also be obtained The reproducibility of SERT binding parameters will be assessed by calculating the variability as well as the intraclass correlation coefficient between testretest measurements We expect that 1 we can accurately quantify SERT binding parameters using 11CDASB PET imaging and 2 11CDASB PET measurements of SERT binding will be reliable and reproducible
1 The NIH RDRC Radioactive Drug Research Committee review of this protocol asked that we obtain human biodistribution data to confirm the expected low levels of radiation exposure based upon our prior studies in monkeys
2 To address one of the criticisms raised by the CSRP review namely 1 to quantify SERT binding parameters with 11CDASB in up to 10 normal subjects and 2 to determine the reliability and reproducibility of SERT binding parameter measurements by performing a second retest 11CDASB PET study in the same subjects because such data are not available for this radioligand PET scanning will be performed with an intravenous injection of 20 mCi of 11CDASB for 2 h during which multiple arterial blood samples will also be obtained The reproducibility of SERT binding parameters will be assessed by calculating the variability as well as the intraclass correlation coefficient between testretest measurements We expect that 1 we can accurately quantify SERT binding parameters using 11CDASB PET imaging and 2 11CDASB PET measurements of SERT binding will be reliable and reproducible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-M-0159 | None | None | None |