|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00407693 |
Purpose
In this study we will examine where the radioactive tracer [11C]PBR28 is distributed in the body of healthy volunteers to calculate the radiation exposure to organs of the body. We will also test if [11C]PBR28 binds to your blood cells and compare with the binding in PET images.
| Condition | Intervention |
|
Healthy |
Drug: [11C]PRB28 |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | PET Whole Body Imaging Using a Peripheral Benzodiazepine Receptor Ligand [C-11]PBR28 |
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2006 |
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 [11C]1-(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 that occurred in vivo. Recently we developed a new ligand, N-acetyl-N-(2-[11C]methoxybenzyl)-2-phenoxy-5-pyridinamine ([11C]PBR28), which showed much greater specific signals than [11C]PK11195 in non-human primates. Therefore, [11C]PBR28 is a promising PET ligand. However, radiation absorbed doses have not been estimated from human whole body imaging.
The purpose of this protocol is to estimate radiation absorbed doses of [11C]PBR28 by performing whole body imaging studies on healthy human subjects. The results of this overall study are required to apply this PET ligand in various neurological and psychiatric disorders in the future.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
All subjects must be healthy and aged 18-65 years.
EXCLUSION CRITERIA:
The exclusion criteria are shown below:
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |||||
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting | ||||
| Bethesda, Maryland, United States, 20892 | |||||
More Information
NIH Clinical Center Detailed Web Page 
  |
| Study ID Numbers: | 070035, 07-M-0035 |
| First Received: | December 2, 2006 |
| Last Updated: | September 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00407693 |
| Health Authority: | United States: Federal Government |
|
|