HealthyPhase 1NCT01399398
Imaging of CB1 Receptors Using (11C)SD5024
A Phase 1 study testing Brain Scan-PET, Brain Scan-MRI and Arterial Line in people with Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Brain Scan-PET, Brain Scan-MRI and Arterial Line
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2011to 18 Dec 2013
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
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: PET Imaging of CB1 Receptors Using [11C]SD5024
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.
Read more
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:
- All participants will be screened with a physical exam, medical history, and blood tests.
- Participants will be in one of three groups for the study. Each group will receive 11C-SD5024 and have a different set of imaging studies.
- Group 1 will have a magnetic resonance imaging (MRI) scan and PET scan of the brain. They will also have blood and urine tests.
- Group 2 will have a whole-body PET scan, as well as blood and urine tests.
- Group 3 will have an MRI scan of the brain, followed by two PET scans of the brain. They will also have blood and urine tests. The two PET scans can happen on the same day or on two different days.
Read the 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.
- Conditions
- Healthy
- Being tested
- Brain Scan-PET, Brain Scan-MRI, Arterial Line, Venous Line, Blood Sampling
- Keywords
- Brain Scan, Kinetic Analysis, Healthy Subjects, Healthy Volunteer, HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Scan-PETProcedure or surgery
Brain Scan-MRIProcedure or surgery
Arterial LineProcedure or surgery
Venous LineProcedure or surgery
Blood SamplingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study start22 Jun 2011
- Primary completion18 Dec 2013
- Study completion18 Dec 2013
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 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Masahiro Fujita, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399398
- Sponsor's protocol ID
- 110202
- Other IDs
- 11-M-0202
- Status last verified
- 18 Dec 2013
- First submitted
- 20 Jul 2011
- Last updated
- 29 Nov 2019
- Results posted
- No
Publications
Burger C, Buck A. Requirements and implementation of a flexible kinetic modeling tool. J Nucl Med. 1997 Nov;38(11):1818-23.
PubMed 9374364Cloutier RJ, Smith SA, Watson EE, Snyder WS, Warner GG. Dose to the fetus from radionuclides in the bladder. Health Phys. 1973 Aug;25(2):147-61. doi: 10.1097/00004032-197308000-00009. No abstract available.
PubMed 4784245Donohue SR, Pike VW, Finnema SJ, Truong P, Andersson J, Gulyas B, Halldin C. Discovery and labeling of high-affinity 3,4-diarylpyrazolines as candidate radioligands for in vivo imaging of cannabinoid subtype-1 (CB1) receptors. J Med Chem. 2008 Sep 25;51(18):5608-16. doi: 10.1021/jm800329z.
PubMed 18754613
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of CB1 Receptors Using [11C]SD5024
- ClinicalTrials.gov ID
- NCT01399398
- Acronym / sponsor ID
- 110202
- Conditions
- Healthy
- Keywords
- Brain Scan, Kinetic Analysis, Healthy Subjects, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 22 Jun 2011
- Primary completion
- 18 Dec 2013 (actual)
- Study completion
- 18 Dec 2013 (actual)
- First posted
- 21 Jul 2011 (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.
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:
- All participants will be screened with a physical exam, medical history, and blood tests.
- Participants will be in one of three groups for the study. Each group will receive 11C-SD5024 and have a different set of imaging studies.
- Group 1 will have a magnetic resonance imaging (MRI) scan and PET scan of the brain. They will also have blood and urine tests.
- Group 2 will have a whole-body PET scan, as well as blood and urine tests.
- Group 3 will have an MRI scan of the brain, followed by two PET scans of the brain. They will also have blood and urine tests. The two PET scans can happen on the same day or on two different days.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Brain Scan-PET | Procedure or surgery | – |
| Brain Scan-MRI | Procedure or surgery | – |
| Arterial Line | Procedure or surgery | – |
| Venous Line | Procedure or surgery | – |
| Blood Sampling | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- 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 4784245Cloutier RJ, Smith SA, Watson EE, Snyder WS, Warner GG. Dose to the fetus from radionuclides in the bladder. Health Phys. 1973 Aug;25(2):147-61. doi: 10.1097/00004032-197308000-00009. No abstract available.
- Background: PubMed 18754613Donohue SR, Pike VW, Finnema SJ, Truong P, Andersson J, Gulyas B, Halldin C. Discovery and labeling of high-affinity 3,4-diarylpyrazolines as candidate radioligands for in vivo imaging of cannabinoid subtype-1 (CB1) receptors. J Med Chem. 2008 Sep 25;51(18):5608-16. doi: 10.1021/jm800329z.
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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.
Masahiro Fujita, M.D. principal investigator
National Institute of Mental Health (NIMH)
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 Brain Scan-PET, Brain Scan-MRI and Arterial Line 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: stopped early, as of the sponsor's last update on 29 Nov 2019. 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 was stopped early. Results are not available in the source record.
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?
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.. 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 NCT01399398, 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 29 Nov 2019.