Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263523
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-12-08
Brief Title:
PET Imaging of Brain 5-HT1A Receptors Using 11C--RWAY
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
PET Imaging of Brain 5-HT1A Receptors Using 11C--RWAY
Status:
COMPLETED
Status Verified Date:
2007-08-15
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 use positron emission tomography PET and magnetic resonance imaging MRI to measure a serotonin receptor subtype in the brain called 5-HT1A This receptor is a target for drug therapy to treat anxiety and depression The study will see if a newly developed radioligand radioactive substance used in PET scanning to study the receptor systems of the brain called 11C--RWAY is more effective than other radioligands currently used in brain receptor research
Healthy subjects 18-40 years of age may be eligible for this study Candidates are screened with a physical examination electrocardiogram and blood and urine tests
Participants undergo PET and MRI scanning as follows
PET scan
PET uses small amounts of a radioactive chemical called a tracer in this case 11C--RWAY that labels active areas of the brain For the procedure the subject lies on the scanner bed A special mask is fitted to the subjects head and attached to the bed to help keep the head still during the scan so the images will be clear A brief scan is done just before the tracer is injected to provide measures of the brain that will help in the precise calculation of information from subsequent scans Then the tracer is injected through a catheter plastic tube placed in the arm and pictures are taken for about 2 hours while the subject lies still on the scanner bed Subjects return to the clinic for blood and urine tests 24 hours after the scan
MRI
The MRI scan is done within 1 year of the PET scan MRI uses a magnetic field and radio waves to produce images of body tissues and organs-in this case the brain The subject lies on a table that is moved into the scanner a tube-like device wearing earplugs to muffle the noise of the machine during the scanning process The space in the scanner is confining and may cause some people to be somewhat anxious An intercom system allows the subject to speak with the staff member performing the study at all times during the procedure and the procedure can be stopped at any time
Healthy subjects 18-40 years of age may be eligible for this study Candidates are screened with a physical examination electrocardiogram and blood and urine tests
Participants undergo PET and MRI scanning as follows
PET scan
PET uses small amounts of a radioactive chemical called a tracer in this case 11C--RWAY that labels active areas of the brain For the procedure the subject lies on the scanner bed A special mask is fitted to the subjects head and attached to the bed to help keep the head still during the scan so the images will be clear A brief scan is done just before the tracer is injected to provide measures of the brain that will help in the precise calculation of information from subsequent scans Then the tracer is injected through a catheter plastic tube placed in the arm and pictures are taken for about 2 hours while the subject lies still on the scanner bed Subjects return to the clinic for blood and urine tests 24 hours after the scan
MRI
The MRI scan is done within 1 year of the PET scan MRI uses a magnetic field and radio waves to produce images of body tissues and organs-in this case the brain The subject lies on a table that is moved into the scanner a tube-like device wearing earplugs to muffle the noise of the machine during the scanning process The space in the scanner is confining and may cause some people to be somewhat anxious An intercom system allows the subject to speak with the staff member performing the study at all times during the procedure and the procedure can be stopped at any time
Detailed Description:
The 5-hydroxytryptamine serotonin 5-HT 5-HT1A receptors subtype is a target for drug therapy in the treatment of anxiety and depression Radioligands currently in use with PET for studying human brain 5-HT1A receptors in clinical research or drug development are based on WAY-100635 Though variously effective they each suffer from one or more drawbacks with respect to measuring relative regional receptor densities These drawbacks include rapid metabolism and very low non-specific binding for carbonyl-11CWAY-100635 defluoridation for 18Ftrans-FCWAY Therefore we have recently developed 11C--RWAY as an alternative radioligand for brain 5 HT1A receptors Even though similar to WAY-100635 11C--RWAY has a reversed amide linkage Reversal of the direction of the amide bond may confer resistance to amide hydrolysis and make acceptable easy labeling at its O-methoxy group In the present protocol we plan to perform a kinetic brain imaging study in healthy human subjects to measure 5 HT1A receptors in brain regions with 11C--RWAY
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 |
|---|---|---|---|
| 06-M-0042 | None | None | None |