Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088517
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-07-27
Brief Title:
Positron Emission Tomography Imaging of Dopamine Receptors Using the Tracer 11CNNC-112
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Whole Body Study of 11CNNC-112 PET Imaging of Dopamine D1 Receptors
Status:
COMPLETED
Status Verified Date:
2006-03
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:
This study will investigate the use of 11CNNC-112 in positron emission tomography PET scanning PET is a technique that uses radioactive isotopes called tracers to provide images of the brain Injected into the body the isotopes lose their radioactive strength over time sending out rays that can be picked up and seen by special detectors connected to a computer The computer then makes a picture of the brain This study will examine the distribution in the body of a new tracer called 11CNNC-112
Healthy normal volunteers between 18 and 70 years of age may be eligible for this study Candidates are screened with a physical examination and blood and urine tests including a urine drug screen Women up to age 55 also have a pregnancy test
Participants have a PET scan using the 11CNNC-112 tracer For this procedure a catheter small plastic tube is placed into a vein in the subjects arm for injecting the tracer Then the subject lies on the scanner bed After a preliminary transmission scan the tracer is injected and PET scans are taken from the head to the upper thigh over a period of about 2 hours to show the distribution of radioactivity in the body Blood pressure breathing rate and heart rate are checked before and after injection of the tracer and blood and urine samples are collected after the PET scan
Healthy normal volunteers between 18 and 70 years of age may be eligible for this study Candidates are screened with a physical examination and blood and urine tests including a urine drug screen Women up to age 55 also have a pregnancy test
Participants have a PET scan using the 11CNNC-112 tracer For this procedure a catheter small plastic tube is placed into a vein in the subjects arm for injecting the tracer Then the subject lies on the scanner bed After a preliminary transmission scan the tracer is injected and PET scans are taken from the head to the upper thigh over a period of about 2 hours to show the distribution of radioactivity in the body Blood pressure breathing rate and heart rate are checked before and after injection of the tracer and blood and urine samples are collected after the PET scan
Detailed Description:
Abnormalities in dopaminergic neurotransmission have been implicated in several neurodegenerative and psychiatric disorders such as Parkinsons disease schizophrenia attention-deficit-hyperactivity disorder and drug dependence Among the Dopamine DA receptors D1 receptors are understood to be involved in the regulation of motor and cognitive activity by modulating DAergic function Neuroreceptor imaging with Positron Emission Tomography PET and Single Photon Emission Computerized Tomography SPECT allows in vivo quantification of the density and distribution of D1 receptors in humans Recently a new and superior PET radioligand for in vivo quantification of D1 receptors in extrastriatal regions has been developed 11CNNC-112 is a D1 radiotracer with high specific to nonspecific binding making it suitable for imaging low density D1 receptors in extrastriatal regions such as the neocortex Several studies in humans have confirmed the potential of this radiotracer however to date dosimetry studies of 11CNNC-112 in humans have not been performed
The specific objective of this protocol is to estimate radiation-absorbed doses of 11CNNC-112 in human subjects For this purpose we propose to perform a kinetic whole body imaging study of 11CNNC-112 in healthy human subjects We hypothesize that the level of radiation-absorbed doses of 11CNNC-112 in humans will be within limits and consequently we should be able to move to the next stage of our imaging research where we will use this radioligand to measure the density and distribution of D1 receptors in Parkinsons disease
The specific objective of this protocol is to estimate radiation-absorbed doses of 11CNNC-112 in human subjects For this purpose we propose to perform a kinetic whole body imaging study of 11CNNC-112 in healthy human subjects We hypothesize that the level of radiation-absorbed doses of 11CNNC-112 in humans will be within limits and consequently we should be able to move to the next stage of our imaging research where we will use this radioligand to measure the density and distribution of D1 receptors in Parkinsons disease
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 |
|---|---|---|---|
| 04-M-0170 | None | None | None |