- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00598286
PET Imaging of Cannabinoid CB1 Receptors Using [18F]FMPEP-d2
Imaging of Cannabinoid CB1 Receptors Using [18F]FMPEP-d2
Study Overview
Status
Conditions
Intervention / Treatment
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 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: [18F]FMPEP-d2 ((3R,5R)-5-(3-(fluoromethoxy)phenyl)-3-((R)-1-phenylethylamino)-1-(4-(trifluoromethyl)phenyl)pyrrolidin-2-one).
Study Population
In the current protocol, we wish to evaluate [18F]FMPEP-d2 in approximately 10 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 [18F]FMPEP-d2 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 [18F]d2-FMPEP have been performed in nonhuman primates; however, these need to be continued in humans before further investigation of this novel tracer can continue.
Study Population
In the current protocol, we wish to evaluate [18F]FMPEP-d2 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.
BRAIN IMAGING WITH TEST/RE-TEST
Objective
Should the brain imaging and dosimetry studies prove to be successful, we will continue with test/retest brain imaging studies. Test/retest studies with [18F]FMPEP-d2 will provide evidence of reproducibility and strengthen the assurance that this radioligand can be used to assess pathology. Previous investigations in developing a CB1 receptor PET tracer have demonstrated the need to test reproducibility (Terry, In Writing; Burns et al 2007).
Study Population
In the current protocol, we wish to evaluate [18F]FMPEP-d2 in approximately 10 additional healthy subjects.
Design
The brain imaging test/retest studies will consist of subject evaluation followed by one MRI and two PET scans.
Outcome Measures
We intend to determine the reproducibility of the outcome measures from the brain imaging, namely, distribution volume.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
- All subjects must be healthy and aged 18-65 years, with history/physical exam, ECG, and laboratory tests within one year of the PET scan.
- The volunteer must sign an informed consent form.
EXCLUSION CRITERIA:
- Current psychiatric illness, substance abuse including marijuana use, or severe systemic disease based on history and physical exam.
- Laboratory tests with clinically significant abnormalities or positive urine toxicology screen.
- Prior participation in other research protocols in the last year such that radiation exposure would exceed the annual limits.
- Pregnancy and breast feeding.
- Claustrophobia.
- Presence of ferromagnetic metal in the body or heart pacemaker.
- Positive HIV test.
- Employee of the investigative site or an immediate family member of an employee of the investigative site. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Employee of Eli Lilly and Company.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Efficacy of novel PET tracer for CB1 in brain imaging.
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Secondary Outcome Measures
Outcome Measure |
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Distribution and variance of CB1 receptors in the brain of healthy controls.
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Collaborators and Investigators
Publications and helpful links
General Publications
- Abi-Dargham A, Gandelman M, Zoghbi SS, Laruelle M, Baldwin RM, Randall P, Zea-Ponce Y, Charney DS, Hoffer PB, Innis RB. Reproducibility of SPECT measurement of benzodiazepine receptors in human brain with iodine-123-iomazenil. J Nucl Med. 1995 Feb;36(2):167-75.
- Burger C, Buck A. Requirements and implementation of a flexible kinetic modeling tool. J Nucl Med. 1997 Nov;38(11):1818-23.
- Burns HD, Van Laere K, Sanabria-Bohorquez S, Hamill TG, Bormans G, Eng WS, Gibson R, Ryan C, Connolly B, Patel S, Krause S, Vanko A, Van Hecken A, Dupont P, De Lepeleire I, Rothenberg P, Stoch SA, Cote J, Hagmann WK, Jewell JP, Lin LS, Liu P, Goulet MT, Gottesdiener K, Wagner JA, de Hoon J, Mortelmans L, Fong TM, Hargreaves RJ. [18F]MK-9470, a positron emission tomography (PET) tracer for in vivo human PET brain imaging of the cannabinoid-1 receptor. Proc Natl Acad Sci U S A. 2007 Jun 5;104(23):9800-5. doi: 10.1073/pnas.0703472104. Epub 2007 May 29.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 080049
- 08-M-0049
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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