Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450021
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2007-03-20
Brief Title:
Imaging of Cannabinoid Receptors Using New Radioactive Tracer
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Imaging of Cannabinoid CB1 Receptors Using 11C MePPEP
Status:
COMPLETED
Status Verified Date:
2008-02-06
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:
This study will test a new radioactive tracer 11CMePPEP for use in positron emission tomography PET imaging The tracer is used to visualize cannabinoid receptors proteins in the brain that mediate a variety of natural chemicals These receptors may be important in behavioral diseases such as addiction obesity and psychiatric diseases
Healthy normal volunteers between 18 and 65 years of age may be eligible for this study
Ten participants undergo whole body PET imaging to determine where the 11CMePPEP tracer is distributed in the body in order to calculate radiation exposure from the tracer Another 10 subjects undergo brain imaging with 11CMePPEP to measure cannabinoid receptors in the brain
All participants are evaluated with a medical history and physical examination blood and urine tests and an electrocardiogram ECG before scanning They then have a PET scan For this procedure a catheter plastic tube is placed in a vein in the arm through which the tracer is injected A special mask is fitted to the head and attached to the bed to help keep the head in place during the scan Subjects undergoing brain imaging also have a catheter placed in an artery in the wrist from which blood samples are collected during the procedure The scan lasts about 2 to 25 hours
Subjects undergoing brain imaging also have magnetic resonance imaging MRI within 1 year of the PET scan For MRI the subject lies on a bed that moves into the tubular scanner wearing earplugs to protect the ears from loud noises that occur during the scan The procedure takes about 1 hour
Healthy normal volunteers between 18 and 65 years of age may be eligible for this study
Ten participants undergo whole body PET imaging to determine where the 11CMePPEP tracer is distributed in the body in order to calculate radiation exposure from the tracer Another 10 subjects undergo brain imaging with 11CMePPEP to measure cannabinoid receptors in the brain
All participants are evaluated with a medical history and physical examination blood and urine tests and an electrocardiogram ECG before scanning They then have a PET scan For this procedure a catheter plastic tube is placed in a vein in the arm through which the tracer is injected A special mask is fitted to the head and attached to the bed to help keep the head in place during the scan Subjects undergoing brain imaging also have a catheter placed in an artery in the wrist from which blood samples are collected during the procedure The scan lasts about 2 to 25 hours
Subjects undergoing brain imaging also have magnetic resonance imaging MRI within 1 year of the PET scan For MRI the subject lies on a bed that moves into the tubular scanner wearing earplugs to protect the ears from loud noises that occur during the scan The procedure takes about 1 hour
Detailed Description:
BRAIN IMAGING
OBJECTIVE
The central cannabinoid receptor CB1 is one of the most abundant neuromodulatory receptors in the brain It is found on glutamatergic dopaminergic and GABA-ergic synaptic terminals and belongs to the G-protein coupled receptor family The CB1 is a target for drug therapy including the use of an antagonist as an appetite suppressant The central cannabinoid receptor CB1 has never been visualized in humans In collaboration with Eli Lilly we developed a promising PET ligand for the CB1 receptor 11CMePPEP This study is known by Eli Lilly as H6O-MC-GCEB
STUDY POPULATION
In the current protocol we wish to evaluate 11CMePPEP in approximately 15 healthy subjects
DESIGN
Brain imaging studies will consist of subject evaluation followed by PET and MRI scans
OUTCOME MEASURES
We intend to determine the kinetics of brain uptake and washout clearance in the plasma and the distribution volume of 11CMePPEP calculated with compartmental modeling Distribution volume is proportional to the density of receptors and is equal to the ratio at equilibrium of uptake in brain to the concentration of parent radiotracer in plasma
WHOLE BODY DOSIMETRY
OBJECTIVE
Should the brain imaging studies prove to be successful we will continue with whole body dosimetry studies Preliminary dosimetry studies with 11CMePPEP have been performed in nonhuman primates however these need to be continued in humans before further investigation of this novel tracer can continue This study is known by Eli Lilly as H6O-MC-GCEC
STUDY POPULATION
In the current protocol we wish to evaluate 11CMePPEP in approximately 10 additional healthy subjects
DESIGN
The whole body dosimetry studies will consist of subject evaluation followed by a PET scan
OUTCOME MEASURES
We intend to determine the whole body distribution of activity and thereby calculate radiation exposure to organs of the body
OBJECTIVE
The central cannabinoid receptor CB1 is one of the most abundant neuromodulatory receptors in the brain It is found on glutamatergic dopaminergic and GABA-ergic synaptic terminals and belongs to the G-protein coupled receptor family The CB1 is a target for drug therapy including the use of an antagonist as an appetite suppressant The central cannabinoid receptor CB1 has never been visualized in humans In collaboration with Eli Lilly we developed a promising PET ligand for the CB1 receptor 11CMePPEP This study is known by Eli Lilly as H6O-MC-GCEB
STUDY POPULATION
In the current protocol we wish to evaluate 11CMePPEP in approximately 15 healthy subjects
DESIGN
Brain imaging studies will consist of subject evaluation followed by PET and MRI scans
OUTCOME MEASURES
We intend to determine the kinetics of brain uptake and washout clearance in the plasma and the distribution volume of 11CMePPEP calculated with compartmental modeling Distribution volume is proportional to the density of receptors and is equal to the ratio at equilibrium of uptake in brain to the concentration of parent radiotracer in plasma
WHOLE BODY DOSIMETRY
OBJECTIVE
Should the brain imaging studies prove to be successful we will continue with whole body dosimetry studies Preliminary dosimetry studies with 11CMePPEP have been performed in nonhuman primates however these need to be continued in humans before further investigation of this novel tracer can continue This study is known by Eli Lilly as H6O-MC-GCEC
STUDY POPULATION
In the current protocol we wish to evaluate 11CMePPEP in approximately 10 additional healthy subjects
DESIGN
The whole body dosimetry studies will consist of subject evaluation followed by a PET scan
OUTCOME MEASURES
We intend to determine the whole body distribution of activity and thereby calculate radiation exposure to organs of the body
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 |
|---|---|---|---|
| 07-M-0118 | None | None | None |