HealthyPhase 1NCT00450021
Imaging of Cannabinoid Receptors Using New Radioactive Tracer
A Phase 1 study testing [(11)C] MePPEP in people with Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This study will test a new radioactive tracer, [(11)C]MePPEP, for use in positron emission tomography (PET) imaging. The tracer is used to visualize cannabinoid receptors, proteins in the brain that mediate a variety of natural chemicals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [(11)C] MePPEP
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2007to 6 Feb 2008
- 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 CB(1) Receptors Using [11C] MePPEP
This study will test a new radioactive tracer, [(11)C]MePPEP, for use in positron emission tomography (PET) imaging. The tracer is used to visualize cannabinoid receptors, proteins in the brain that mediate a variety of natural chemicals. These receptors may be important in behavioral diseases such as addiction, obesity and psychiatric diseases.
Healthy normal volunteers between 18 and 65 years of age may be eligible for this study.
Read more
Ten participants undergo whole body PET imaging to determine where the [(11)C]MePPEP tracer is distributed in the body in order to calculate radiation exposure from the tracer. Another 10 subjects undergo brain imaging with [(11)C]MePPEP to measure cannabinoid receptors in the brain.
All participants are evaluated with a medical history and physical examination, blood and urine tests and an electrocardiogram (ECG) before scanning. They then have a PET scan. For this procedure, a catheter (plastic tube) is placed in a vein in the arm through which the tracer is injected. A special mask is fitted to the head and attached to the bed to help keep the head in place during the scan. Subjects undergoing brain imaging also have a catheter placed in an artery in the wrist from which blood samples are collected during the procedure. The scan lasts about 2 to 2.5 hours.
Subjects undergoing brain imaging also have magnetic resonance imaging (MRI) within 1 year of the PET scan. For MRI, the subject lies on a bed that moves into the tubular scanner, wearing earplugs to protect the ears from loud noises that occur during the scan. The procedure takes about 1 hour.
Read the detailed description
BRAIN IMAGING:
OBJECTIVE:
The central cannabinoid receptor, CB(1) 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 the G-protein coupled receptor family. The CB(1) is a target for drug therapy, including the use of an antagonist as an appetite suppressant. The central cannabinoid receptor CB(1) has never been visualized in humans. In collaboration with Eli Lilly, we developed a promising PET ligand for the CB(1) receptor: [(11)C]MePPEP. This study is known by Eli Lilly as H6O-MC-GCEB.
STUDY POPULATION:
In the current protocol, we wish to evaluate [(11)C]MePPEP in approximately 15 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 [(11)C]MePPEP 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 [(11)C]MePPEP have been performed in nonhuman primates; however, these need to be continued in humans before further investigation of this novel tracer can continue. This study is known by Eli Lilly as H6O-MC-GCEC.
STUDY POPULATION:
In the current protocol, we wish to evaluate [(11)C]MePPEP 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.
- Conditions
- Healthy
- Being tested
- [(11)C] MePPEP
- Keywords
- PET, CB1 Receptor, Cannabinoid, [11C] MePPEP, Brain Imaging, Healthy Volunteer, HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[(11)C] MePPEPDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of novel PET tracer for DB! in Brain imaging.
Secondary outcomes (1)
Safety and radiation dosimetry of PET tracer [11C] MePPEP; 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 Mar 2007 (estimated)
- Study start19 Mar 2007
- Primary completion6 Feb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 25 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Mental Health, Eli Lilly & Co.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450021
- Sponsor's protocol ID
- 070118
- Other IDs
- 07-M-0118
- Status last verified
- 6 Feb 2008
- First submitted
- 20 Mar 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Carson RE, Huang SC, Green MV. Weighted integration method for local cerebral blood flow measurements with positron emission tomography. J Cereb Blood Flow Metab. 1986 Apr;6(2):245-58. doi: 10.1038/jcbfm.1986.38.
PubMed 3485644
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Cannabinoid CB(1) Receptors Using [11C] MePPEP
- ClinicalTrials.gov ID
- NCT00450021
- Acronym / sponsor ID
- 070118
- Conditions
- Healthy
- Keywords
- PET, CB1 Receptor, Cannabinoid, [11C] MePPEP, Brain Imaging, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Collaborators
- National Institute of Mental Health, Eli Lilly & Co.
- Study start
- 19 Mar 2007
- Primary completion
- 6 Feb 2008 (actual)
- First posted
- 21 Mar 2007 (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.
This study will test a new radioactive tracer, [(11)C]MePPEP, for use in positron emission tomography (PET) imaging. The tracer is used to visualize cannabinoid receptors, proteins in the brain that mediate a variety of natural chemicals. These receptors may be important in behavioral diseases such as addiction, obesity and psychiatric diseases.
Healthy normal volunteers between 18 and 65 years of age may be eligible for this study.
Ten participants undergo whole body PET imaging to determine where the [(11)C]MePPEP tracer is distributed in the body in order to calculate radiation exposure from the tracer. Another 10 subjects undergo brain imaging with [(11)C]MePPEP to measure cannabinoid receptors in the brain.
All participants are evaluated with a medical history and physical examination, blood and urine tests and an electrocardiogram (ECG) before scanning. They then have a PET scan. For this procedure, a catheter (plastic tube) is placed in a vein in the arm through which the tracer is injected. A special mask is fitted to the head and attached to the bed to help keep the head in place during the scan. Subjects undergoing brain imaging also have a catheter placed in an artery in the wrist from which blood samples are collected during the procedure. The scan lasts about 2 to 2.5 hours.
Subjects undergoing brain imaging also have magnetic resonance imaging (MRI) within 1 year of the PET scan. For MRI, the subject lies on a bed that moves into the tubular scanner, wearing earplugs to protect the ears from loud noises that occur during the scan. The procedure takes about 1 hour.
Detailed description
BRAIN IMAGING:
OBJECTIVE:
The central cannabinoid receptor, CB(1) 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 the G-protein coupled receptor family. The CB(1) is a target for drug therapy, including the use of an antagonist as an appetite suppressant. The central cannabinoid receptor CB(1) has never been visualized in humans. In collaboration with Eli Lilly, we developed a promising PET ligand for the CB(1) receptor: [(11)C]MePPEP. This study is known by Eli Lilly as H6O-MC-GCEB.
STUDY POPULATION:
In the current protocol, we wish to evaluate [(11)C]MePPEP in approximately 15 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 [(11)C]MePPEP 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 [(11)C]MePPEP have been performed in nonhuman primates; however, these need to be continued in humans before further investigation of this novel tracer can continue. This study is known by Eli Lilly as H6O-MC-GCEC.
STUDY POPULATION:
In the current protocol, we wish to evaluate [(11)C]MePPEP 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.
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 (1 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 |
|---|---|---|
| [(11)C] MePPEP | Drug | – |
Primary outcome
Efficacy of novel PET tracer for DB! in Brain imaging.
1 secondary outcome
Safety and radiation dosimetry of PET tracer [11C] MePPEP; 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 2 Jul 2017.
- Background: PubMed 3485644Carson RE, Huang SC, Green MV. Weighted integration method for local cerebral blood flow measurements with positron emission tomography. J Cereb Blood Flow Metab. 1986 Apr;6(2):245-58. doi: 10.1038/jcbfm.1986.38.
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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 [(11)C] MePPEP in people with Healthy, 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 1 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 2 Jul 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 DB! 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 NCT00450021, which also lists 1 linked publication.
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 2 Jul 2017.