CB1Phase 1NCT00598286
PET Imaging of Cannabinoid CB1 Receptors Using [18F]FMPEP-d2
A Phase 1 study testing [18F]FMPEP-d2 in people with CB1 and Cannabinoid, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this protocol is to measure brain CB1 receptors in the hope to better understand how they work, so that one day we can understand how the CB1 receptors are involved in psychiatric, neurological, and behavioral disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- CB1, Cannabinoid, PET
- What is being tested?
- [18F]FMPEP-d2
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Oct 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Imaging of Cannabinoid CB1 Receptors Using [18F]FMPEP-d2
The purpose of this protocol is to measure brain CB1 receptors in the hope to better understand how they work, so that one day we can understand how the CB1 receptors are involved in psychiatric, neurological, and behavioral disorders.
Read the 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.
- Conditions
- CB1, Cannabinoid, PET, Brain Imaging
- Being tested
- [18F]FMPEP-d2
- Keywords
- CB1 Receptor, PET, Cannabinoid, [18F]FMPEP-d2, Brain Imaging, Healthy Volunteer, HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FMPEP-d2Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of novel PET tracer for CB1 in brain imaging.
Secondary outcomes (1)
Distribution and variance of CB1 receptors in the brain of healthy controls.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CB1Studies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598286
- Sponsor's protocol ID
- 080049
- Other IDs
- 08-M-0049
- Status last verified
- May 2012
- First submitted
- 10 Jan 2008
- Last updated
- 27 Oct 2017
- Results posted
- No
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.
PubMed 7830108Burger C, Buck A. Requirements and implementation of a flexible kinetic modeling tool. J Nucl Med. 1997 Nov;38(11):1818-23.
PubMed 9374364Burns 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.
PubMed 17535893
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Cannabinoid CB1 Receptors Using [18F]FMPEP-d2
- ClinicalTrials.gov ID
- NCT00598286
- Acronym / sponsor ID
- 080049
- Conditions
- CB1, Cannabinoid, PET, Brain Imaging
- Keywords
- CB1 Receptor, PET, Cannabinoid, [18F]FMPEP-d2, Brain Imaging, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Jan 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to measure brain CB1 receptors in the hope to better understand how they work, so that one day we can understand how the CB1 receptors are involved in psychiatric, neurological, and behavioral disorders.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FMPEP-d2 | Drug | – |
Primary outcome
Efficacy of novel PET tracer for CB1 in brain imaging.
1 secondary outcome
Distribution and variance of CB1 receptors in the brain of healthy controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Background: PubMed 7830108Abi-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.
- Background: PubMed 9374364Burger C, Buck A. Requirements and implementation of a flexible kinetic modeling tool. J Nucl Med. 1997 Nov;38(11):1818-23.
- Background: PubMed 17535893Burns 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]FMPEP-d2 in people with CB1 and Cannabinoid, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of novel PET tracer for CB1 in brain imaging.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00598286, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.