Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283920
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-01-29
Brief Title:
PET Imaging of Brain Peripheral Benzodiazepine Receptors
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
PET Imaging of Brain Peripheral Type Benzodiazepine Receptors
Status:
COMPLETED
Status Verified Date:
2007-10-02
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 peripheral benzodiazepine receptors PBRs in the brain PBRs were initially found in peripheral organs such as kidneys endocrine glands and lungs but later studies identified PBRs in the CNS PBRs can be a marker to detect nervous system inflammation Development of a test to image PBRs may improve the management of brain disorders such as multiple sclerosis Alzheimers disease Parkinsons disease and others in which inflammation is involved in progression of the disease
Healthy volunteers from 18 to 40 years old may be eligible for this study Candidates are screened with tests that may include some or all of the following diagnostic interview ratings of mood anxiety functioning and other parameters neuropsychological testing physical examination electrocardiogram blood and urine tests and personal social and family histories
Participants undergo the following procedures
Evaluation Subjects provide a medical history including detailed questions about their psychological health and have a physical examination and blood and urine tests
PET scanning PET uses small amounts of a radioactive chemical called a tracer that labels active areas of the brain The tracer used in this study is 11CPBR28 For the procedure the subject lies on the scanner bed A special mask is fitted to the 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 radioactive tracer is injected to provide measures of the brain that will help to precisely calculate information from subsequent scans After the tracer is injected through a catheter plastic tube placed in the arm pictures are taken for 2 to 3 hours during which the subject lies still on the scanner bed Subjects return to the clinic the following day for more blood and urine sample collections
MRI The MRI scan is done within 1 year of the PET scan either before or after the PET MRI uses magnetic fields and radio waves to produce images of the brain The patient lies on a table that is moved into the scanner a narrow cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process He or she can communicate with the staff at all times during the procedure
Healthy volunteers from 18 to 40 years old may be eligible for this study Candidates are screened with tests that may include some or all of the following diagnostic interview ratings of mood anxiety functioning and other parameters neuropsychological testing physical examination electrocardiogram blood and urine tests and personal social and family histories
Participants undergo the following procedures
Evaluation Subjects provide a medical history including detailed questions about their psychological health and have a physical examination and blood and urine tests
PET scanning PET uses small amounts of a radioactive chemical called a tracer that labels active areas of the brain The tracer used in this study is 11CPBR28 For the procedure the subject lies on the scanner bed A special mask is fitted to the 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 radioactive tracer is injected to provide measures of the brain that will help to precisely calculate information from subsequent scans After the tracer is injected through a catheter plastic tube placed in the arm pictures are taken for 2 to 3 hours during which the subject lies still on the scanner bed Subjects return to the clinic the following day for more blood and urine sample collections
MRI The MRI scan is done within 1 year of the PET scan either before or after the PET MRI uses magnetic fields and radio waves to produce images of the brain The patient lies on a table that is moved into the scanner a narrow cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process He or she can communicate with the staff at all times during the procedure
Detailed Description:
The peripheral benzodiazepine receptor PBR is distinct from central benzodiazepine receptors associated with GABAA receptors Although PBR was initially identified in peripheral organs such as kidneys endocrine glands and lungs later studies identified PBR in the central nervous system In normal conditions PBR is expressed in low levels in some neurons and glial cells PBR can be a clinically useful marker to detect neuroinflammation because activated microglial cells in inflammatory areas express much greater levels of PBR than in microglial cells in resting conditions
PBR has been imaged with positron emission tomography PET using 11C1-2-chlorophenyl-N-methylpropyl-3-isoquinoline carboxamide PK11195 However this classical ligand provides only low levels of specific signals and is not sensitive to detect changes occurred in vivo Recently we developed a new ligand N-acetyl-N-2-methoxybenzyl-2-phenoxy-5-pyridinamine 11CPBR28 which showed much greater specific signals than 11CPK11195 in non-human primates In the present protocol we plan to perform a kinetic brain imaging study in healthy human subjects to measure PBR in brain regions with 11CPBR28 Successful development of a PET ligand to image PBR will have a strong impact on clinical management of brain disorders with inflammation such as multiple sclerosis and ischemia and neurodegenerative disorders such as Alzheimers and Parkinsons disease where inflammation is involved in the disease progression
PBR has been imaged with positron emission tomography PET using 11C1-2-chlorophenyl-N-methylpropyl-3-isoquinoline carboxamide PK11195 However this classical ligand provides only low levels of specific signals and is not sensitive to detect changes occurred in vivo Recently we developed a new ligand N-acetyl-N-2-methoxybenzyl-2-phenoxy-5-pyridinamine 11CPBR28 which showed much greater specific signals than 11CPK11195 in non-human primates In the present protocol we plan to perform a kinetic brain imaging study in healthy human subjects to measure PBR in brain regions with 11CPBR28 Successful development of a PET ligand to image PBR will have a strong impact on clinical management of brain disorders with inflammation such as multiple sclerosis and ischemia and neurodegenerative disorders such as Alzheimers and Parkinsons disease where inflammation is involved in the disease progression
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-0073 | None | None | None |