Imaging of CB1 Receptors Using (11C)SD5024
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ClinicalTrials.gov Identifier: NCT01399398 |
Recruitment Status
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Terminated
First Posted
: July 21, 2011
Last Update Posted
: April 20, 2018
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Tracking Information | ||||
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First Submitted Date ICMJE | July 20, 2011 | |||
First Posted Date ICMJE | July 21, 2011 | |||
Last Update Posted Date | April 20, 2018 | |||
Study Start Date ICMJE | June 22, 2011 | |||
Actual Primary Completion Date | December 18, 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
For the PET scans, we will measure the regional densities of cannabinoid 1 receptors as distribution volume (VT). Distribution volume is the ratio at equilibrium of brain uptake to the concentration of parent radioligand in plasma. | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01399398 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Imaging of CB1 Receptors Using (11C)SD5024 | |||
Official Title ICMJE | PET Imaging of CB1 Receptors Using [11C]SD5024 | |||
Brief Summary | Background: - The cannabinoid type 1 (CB1) receptor is a protein found on some brain cells. It may play a role in obesity or some psychiatric disorders such as schizophrenia. Imaging studies like positron emission tomography (PET) can show where CB1 receptors are located. A new radioactive chemical, 11C-SD5024, may be able to show these receptors more clearly than previous radioactive chemicals. Better images of CB1 receptors in the brain may help improve our understanding of obesity and psychiatric disorders. This information may lead to better treatments. Objectives: - To test how well a new radioactive chemical, 11C-SD5024, is taken up by the brain during imaging studies. Eligibility: - Healthy volunteers between 18 and 50 years of age who are able to have positron emission tomography scans. Design:
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Detailed Description | The cannabinoid type 1 (CB(1)) receptor is one of the most abundant G protein-coupled receptors in the brain (Matsuda et al 1990). It is found on glutamatergic, dopaminergic, and gamma aminobutyric acid (GABA)-ergic synaptic terminals and mediates the effects of endocannabinoids (ECs), which suppresses the release of neurotransmitters. The CB(1) receptor is a target for drug therapy, including the use of a CB(1) receptor antagonist as an appetite suppressant. Our laboratory recently developed a promising positron emission tomography (PET) ligand for the CB(1) receptor: [(11)C]SD5024 (Donohue et al 2008a). Previous studies from our laboratory used two PET ligands to image CB(1) receptors (11)C-MePPEP and (18)F-FMPEP-d(2) (Yasuno et al 2008; Donohue et al 2008b) and found that the latter provides more accurate and precise measurement. We also found that clearance of (11)C-MePPEP from brain was too slow for (11)C-labeling (Terry et al 2010). Although we are currently using [(18)F]FMPEP-d(2) , the major disadvantage of the current radioligand is that it washes out slowly from the brain, and accurate quantitation requires relatively fast washout. If [(11)C]SD5024 is amenable to quantitation in human subjects, then it may prove to be a useful ligand for studying potential pathophysiological changes of this receptor. The purpose of this protocol is (1) to perform brain imaging using [(11)C]SD5024 in healthy volunteers to characterize brain uptake and distribution; (2) to perform whole body PET studies in healthy volunteers in order to estimate radiation absorbed doses for [(11)C]SD5024; and (3) to perform brain test-retest studies in healthy volunteers to further examine how precise measurements of receptor binding are, and to determine optimal parameters for future experiments using [(11)C]SD5024. Successful development of a PET radioligand to image CB1 receptors has the potential to significantly impact our understanding and clinical management of neuropsychiatric (eg, schizophrenia) (Eggan et al 2008) and metabolic (eg, obesity) (Gazzerro et al 2007) disorders. Future experiments would include studies of relevant neuropsychiatric disorders. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
8 | |||
Original Estimated Enrollment ICMJE |
35 | |||
Actual Study Completion Date | December 18, 2013 | |||
Actual Primary Completion Date | December 18, 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE |
Healthy control subjects aged 18 50 whose medical history, physical exam, electrocardiogram (ECG), and laboratory test results are within normal limits within one year of the PET scan will be eligible to participate. EXCLUSION CRITERIA: Any recent or past history of psychiatric illness or severe systemic disease based on history and physical exam. Serious medical illness likely to modify brain anatomy and/or physiology (head trauma, past brain surgery, neurological disorders such as epilepsy, Parkinson disease, and psychiatric disorders such as schizophrenia and depression) Any current substance or alcohol abuse, with the exception of nicotine. Positive urine toxicology screen Radiation exposure from participation in other research protocols in the last year such that the additional radiation exposure from this protocol would exceed annual limits. Pregnant or breastfeeding. Claustrophobia (applies to Parts 1 and 3 only). Metallic (ferromagnetic) implants, including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, shrapnel fragments, and possible small metal fragments in the eye (applies to Parts 1 and 3 only). Unable to lie flat on back for up to 2.5 hours. |
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01399398 | |||
Other Study ID Numbers ICMJE | 110202 11-M-0202 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ) | |||
Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Institutes of Health Clinical Center (CC) | |||
Verification Date | December 18, 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |