Nervous System DiseasePhase 1/2NCT02743377
PET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of McCune-Albright Syndrome
A Phase 1/2 study testing Brain PET Imaging with 11C Rolipram, Whole Body PET Baseline with 11C Rolipram and Whole Body PET Blocked with Roflumilast in people with Nervous System Disease, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: McCune-Albright Syndrome (MAS) is a disorder that affects the bones, skin, and some hormone-producing tissues. It is associated with a mutation in a gene. This gene affects enzymes in the brain and body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nervous System Disease
- What is being tested?
- Brain PET Imaging with 11C Rolipram, Whole Body PET Baseline with 11C Rolipram and Whole Body PET Blocked with Roflumilast
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2018to 19 May 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with MAS:
- At least 18 years of age
- Able to provide self-consent
- Diagnosed with MAS under 98-D-0145.
- Have craniofacial fibrous dysplasia
- Healthy Subjects:
- At least 18 years of age.
- Healthy based on medical history and physical examination.
Who cannot join
- Subjects with MAS:
- Serious medical conditions, which may interfere with study procedures. Such conditions include but not limited to significant bone abnormalities in wrist areas of both arms, which makes it difficult to place a radial arterial line, clinically marked dysfunction of liver or kidney, which may delay clearance of [(11)C](R)-rolipram.
- Clinically significant laboratory abnormalities not linked to endocrine abnormalities but that may interfere with the PET measurement or affect safety of the participant during this study.
- Positive HIV test.
- Head trauma resulting in a period of unconsciousness lasting longer than one hour.
- Metallic foreign bodies that would be affected by the magnetic resonance imaging (MRI) magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.
Show all 22Show fewer
- Recent research-related exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits.
- Inability to lie flat on camera bed for about two and a half hours.
- Pregnancy or breastfeeding.
- NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy.
- Healthy Subjects:
- Serious medical conditions, which may interfere with study procedures. Such conditions include but not limited to clinically marked dysfunction of liver or kidney, which may delay clearance of [(11)C](R)-rolipram.
- Clinically significant laboratory abnormalities that may interfere with the PET measurement or affect safety of the participant during this study.
- Personal history of any DSM Axis I disorder.
- Positive HIV test.
- Head trauma resulting in a period of unconsciousness lasting longer than one hour.
- Metallic foreign bodies that would be affected by the MRI magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.
- Recent research-related exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits.
- Inability to lie flat on camera bed for about two and a half hours.
- Pregnancy or breastfeeding.
- Current substance use disorder based on DSM.
- NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: PET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of Mccune-Albright Syndrome
Background:
McCune-Albright Syndrome (MAS) is a disorder that affects the bones, skin, and some hormone-producing tissues. It is associated with a mutation in a gene. This gene affects enzymes in the brain and body. Researchers want to learn more about one of these enzymes, Phosphodiesterase 4 (PDE4), in people with MAS.
Read more
Objective:
To see if people with MAS have higher levels of PDE4 than people without MAS.
Eligibility:
People ages 18 and older who have MAS and participated in protocol 98-D-0145, Screening and Natural History of Patients with Polyostotic Fibrous Dysplasia and the McCune-Albright Syndrome. Healthy adult volunteers are also needed.
Design:
This study requires 1 to 4 outpatient visits to the NIH Clinical Center. Some visits may take place on the same day.
Participants with MAS will be screened with medical history and physical exam. They will have blood and urine tests.
Participants will have a magnetic resonance imaging scan.
Participants will have a full body positron emission tomography (PET) scan. A small amount of a radioactive chemical, [11C](R)-rolipram, will be given through an intravenous tube.
Participants will have a brain PET scan with [11C](R)-rolipram. For this, a thin plastic tube will also be put into an artery at their wrist or elbow crease area.
For the scans, participants will lie on a bed that slides in and out of a scanner. They may wear a plastic mask to hold their head in place. They will have blood drawn.
Participants with MAS will be interviewed about their thinking and mood. They may complete questionnaires about how they feel or think.
Read the detailed description
Objective: McCune-Albright syndrome (MAS) is a mosaic disease arising from early embryonic somatic activating mutations of GNAS, which encodes the 3 <=, 5 <=-cyclic adenosine monophosphate (cAMP) pathway-associated G-protein, Gs . Constitutive activation of Gs leads to increased cAMP signaling in brain, as well as in peripheral organs, particularly bones. Although subjects with MAS show psychiatric and neurological symptoms, few studies have attempted to assess brain changes in these individuals. This protocol seeks to study changes in the cAMP cascade both in brain and peripheral organs of individuals with MAS using [11C](R)-rolipram PET, which binds to phosphodiesterase 4 (PDE4) and reflects cAMP cascade activity.
Study population: Participants will include 20 subjects with MAS and 15 healthy subjects group-matched to MAS subjects for age and gender. Both MAS subjects and healthy controls will have one or two PET scans: one whole body and one brain scan. We expect about 10 brain and 10 whole body scan to be performed in each group.
Design: Subjects with MAS will be recruited from participants in 98-D-0145 Screening and Natural History of Patients with Polyostotic Fibrous Dysplasia and the McCune-Albright Syndrome (PI: Alison M. Boyce, MD). Only participants in protocol (98-D-0145) who provided self-consent without a legally authorized representative will be recruited. Brain PET scans will be performed by measuring metabolite-corrected arterial input function. No venous blood sampling will be performed for whole body scans.
Outcome measures: The primary outcome measure will be obtained in brain scans as the amount of radioligand binding quantified as distribution volume (Vt). Calculated from both brain and plasma data, Vt reflects rolipram binding to PDE4, corrected for any individual differences in metabolism of the radioligand or regional blood flow in brain. The secondary outcome measure will be obtained in whole body scans as area under the curve (AUC) of radioactivity expressed as standard uptake value (SUV). SUV is calculated by normalizing radioactivity in PET images to injection activity and body weight. Vt in brain will be compared between subjects with MAS and healthy controls. AUC will be compared within-subjects with MAS between areas of craniofacial fibrous dysplasia and adjacent unaffected bone. AUC of whole body scans will also be compared between subjects with MAS and healthy controls. We hypothesize that subjects with MAS will show greater rolipram binding than healthy controls in brain regions, as well as greater rolipram uptake in bones affected by fibrous dysplasia than in unaffected bones.
- Conditions
- Nervous System Disease
- Being tested
- Brain PET Imaging with 11C Rolipram, Whole Body PET Baseline with 11C Rolipram, Whole Body PET Blocked with Roflumilast
- Keywords
- GsI+/-, Camp, GNAS
- Medical subject headings
- Nervous System Diseases, Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain PET Imaging with 11C RolipramOther
Brain PET Imaging, single scan, with 11C Rolipram 20 mCi given intravenously at the start of the scan
Whole Body PET Baseline with 11C RolipramDrug
Whole Body Baseline PET Imaging, single scan, with 11C Rolipram 20 mCi given intravenously at the start of the scan
Whole Body PET Blocked with RoflumilastDrug
Whole Body PET Imaging scan after blockade with Roflumilast 500 mcg PO, given 1-2 hours prior to start of scan
| Study group | Role | What they receive |
|---|---|---|
| Subjects with McCune-Albright syndrome (MAS) | Experimental | Subjects with McCune-Albright syndrome (MAS) who received 11C-(R)-rolipram whole-body and/or brain PET scans Receives: Other: Brain PET Imaging with 11C Rolipram; Drug: Whole Body PET Baseline with 11C Rolipram; Drug: Whole Body PET Blocked with Roflumilast |
| Healthy control | Experimental | Healthy control received 11C-(R)-rolipram whole-body and/or brain PET scans Receives: Other: Brain PET Imaging with 11C Rolipram; Drug: Whole Body PET Baseline with 11C Rolipram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) - Bladder
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls.
Measured: 120 minutes
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) -Gallbladder
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls.
Measured: 120 minutes
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) - Heart
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls.
Measured: 120 minutes
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) - Kidneys
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls.
Measured: 120 minutes
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) - Liver
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls
Measured: 120 minutes
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) - Lungs
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls
Measured: 120 minutes
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) -Spleen
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls
Measured: 120 minutes
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) - Stomach
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls
Measured: 120 minutes
Whole Brain Total Distribution Volume (VT)
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the brain of patients with McCune-Albright Syndrome (MAS) compared to healthy controls
Measured: 90 minutes
MAS Affected Bone SUV AUC(60-120min) at Baseline
To assess whether uptake in dysplastic bone reflects parent radioligand binding to the enzyme or merely accumulation of radiometabolites
Measured: 120 minutes
MAS Affected Bone SUV AUC(60-120min) - Blocked
To assess whether uptake in dysplastic bone reflects parent radioligand binding to the enzyme or merely accumulation of radiometabolites
Measured: 120 minutes
Secondary outcomes (2)
MAS Affected Bone SUV AUC(60-120min) - for Baseline and Blocked Subjects With MAS
Determine if PDE4 levels are different in areas of fibrous dysplasia as compared to unaffected bones in patients with MAS
Measured: 120 minutes
Normal Bone SUV AUC (60-120min) - for Healthy Controls
Determine if PDE4 levels are different in areas of fibrous dysplasia as compared to unaffected bones in patients with MAS
Measured: 120 minutes after the start of the scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start4 Apr 2018
- Primary completion23 Oct 2019
- Study completion19 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nervous System DiseaseStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert B Innis, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743377
- Sponsor's protocol ID
- 160093
- Other IDs
- 16-M-0093
- Status last verified
- 19 May 2020
- First submitted
- 15 Apr 2016
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of Mccune-Albright Syndrome
- ClinicalTrials.gov ID
- NCT02743377
- Acronym / sponsor ID
- 160093
- Conditions
- Nervous System Disease
- Keywords
- GsI+/-, Camp, GNAS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
McCune-Albright Syndrome (MAS) is a disorder that affects the bones, skin, and some hormone-producing tissues. It is associated with a mutation in a gene. This gene affects enzymes in the brain and body. Researchers want to learn more about one of these enzymes, Phosphodiesterase 4 (PDE4), in people with MAS.
Objective:
To see if people with MAS have higher levels of PDE4 than people without MAS.
Eligibility:
People ages 18 and older who have MAS and participated in protocol 98-D-0145, Screening and Natural History of Patients with Polyostotic Fibrous Dysplasia and the McCune-Albright Syndrome. Healthy adult volunteers are also needed.
Design:
This study requires 1 to 4 outpatient visits to the NIH Clinical Center. Some visits may take place on the same day.
Participants with MAS will be screened with medical history and physical exam. They will have blood and urine tests.
Participants will have a magnetic resonance imaging scan.
Participants will have a full body positron emission tomography (PET) scan. A small amount of a radioactive chemical, [11C](R)-rolipram, will be given through an intravenous tube.
Participants will have a brain PET scan with [11C](R)-rolipram. For this, a thin plastic tube will also be put into an artery at their wrist or elbow crease area.
For the scans, participants will lie on a bed that slides in and out of a scanner. They may wear a plastic mask to hold their head in place. They will have blood drawn.
Participants with MAS will be interviewed about their thinking and mood. They may complete questionnaires about how they feel or think.
Detailed description
Objective: McCune-Albright syndrome (MAS) is a mosaic disease arising from early embryonic somatic activating mutations of GNAS, which encodes the 3 <=, 5 <=-cyclic adenosine monophosphate (cAMP) pathway-associated G-protein, Gs . Constitutive activation of Gs leads to increased cAMP signaling in brain, as well as in peripheral organs, particularly bones. Although subjects with MAS show psychiatric and neurological symptoms, few studies have attempted to assess brain changes in these individuals. This protocol seeks to study changes in the cAMP cascade both in brain and peripheral organs of individuals with MAS using [11C](R)-rolipram PET, which binds to phosphodiesterase 4 (PDE4) and reflects cAMP cascade activity.
Study population: Participants will include 20 subjects with MAS and 15 healthy subjects group-matched to MAS subjects for age and gender. Both MAS subjects and healthy controls will have one or two PET scans: one whole body and one brain scan. We expect about 10 brain and 10 whole body scan to be performed in each group.
Design: Subjects with MAS will be recruited from participants in 98-D-0145 Screening and Natural History of Patients with Polyostotic Fibrous Dysplasia and the McCune-Albright Syndrome (PI: Alison M. Boyce, MD). Only participants in protocol (98-D-0145) who provided self-consent without a legally authorized representative will be recruited. Brain PET scans will be performed by measuring metabolite-corrected arterial input function. No venous blood sampling will be performed for whole body scans.
Outcome measures: The primary outcome measure will be obtained in brain scans as the amount of radioligand binding quantified as distribution volume (Vt). Calculated from both brain and plasma data, Vt reflects rolipram binding to PDE4, corrected for any individual differences in metabolism of the radioligand or regional blood flow in brain. The secondary outcome measure will be obtained in whole body scans as area under the curve (AUC) of radioactivity expressed as standard uptake value (SUV). SUV is calculated by normalizing radioactivity in PET images to injection activity and body weight. Vt in brain will be compared between subjects with MAS and healthy controls. AUC will be compared within-subjects with MAS between areas of craniofacial fibrous dysplasia and adjacent unaffected bone. AUC of whole body scans will also be compared between subjects with MAS and healthy controls. We hypothesize that subjects with MAS will show greater rolipram binding than healthy controls in brain regions, as well as greater rolipram uptake in bones affected by fibrous dysplasia than in unaffected bones.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with McCune-Albright syndrome (MAS) | Experimental | Other: Brain PET Imaging with 11C Rolipram, Drug: Whole Body PET Baseline with 11C Rolipram, Drug: Whole Body PET Blocked with RoflumilastSubjects with McCune-Albright syndrome (MAS) who received 11C-(R)-rolipram whole-body and/or brain PET scans |
| Healthy control | Experimental | Other: Brain PET Imaging with 11C Rolipram, Drug: Whole Body PET Baseline with 11C RolipramHealthy control received 11C-(R)-rolipram whole-body and/or brain PET scans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age
- Able to provide self-consent
- Diagnosed with MAS under 98-D-0145.
- Have craniofacial fibrous dysplasia
- At least 18 years of age.
Key exclusion criteria (22 listed)
- Serious medical conditions, which may interfere with study procedures. Such conditions include but not limited to significant bone abnormalities in wrist areas of both arms, which makes it difficult to place a radial arterial line, clinically marked dysfunction of liver or kidney, which may delay clearance of [(11)C](R)-rolipram.
- Clinically significant laboratory abnormalities not linked to endocrine abnormalities but that may interfere with the PET measurement or affect safety of the participant during this study.
- Positive HIV test.
- Head trauma resulting in a period of unconsciousness lasting longer than one hour.
- Metallic foreign bodies that would be affected by the magnetic resonance imaging (MRI) magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.
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 PET Imaging with 11C RolipramBrain PET Imaging, single scan, with 11C Rolipram 20 mCi given intravenously at the start of the scan | Other | Healthy control, Subjects with McCune-Albright syndrome (MAS) |
| Whole Body PET Baseline with 11C RolipramWhole Body Baseline PET Imaging, single scan, with 11C Rolipram 20 mCi given intravenously at the start of the scan | Drug | Healthy control, Subjects with McCune-Albright syndrome (MAS) |
| Whole Body PET Blocked with RoflumilastWhole Body PET Imaging scan after blockade with Roflumilast 500 mcg PO, given 1-2 hours prior to start of scan | Drug | Subjects with McCune-Albright syndrome (MAS) |
Primary outcome
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) - Bladder
Time frame: 120 minutes
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls.
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) -Gallbladder
Time frame: 120 minutes
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls.
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) - Heart
Time frame: 120 minutes
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls.
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) - Kidneys
Time frame: 120 minutes
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls.
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) - Liver
Time frame: 120 minutes
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) - Lungs
Time frame: 120 minutes
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) -Spleen
Time frame: 120 minutes
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) - Stomach
Time frame: 120 minutes
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the periphery of patients with McCune-Albright Syndrome (MAS) compared to healthy controls
Whole Brain Total Distribution Volume (VT)
Time frame: 90 minutes
Determine if there is a difference in PDE4 levels (measured using [11C]rolipram) in the brain of patients with McCune-Albright Syndrome (MAS) compared to healthy controls
MAS Affected Bone SUV AUC(60-120min) at Baseline
Time frame: 120 minutes
To assess whether uptake in dysplastic bone reflects parent radioligand binding to the enzyme or merely accumulation of radiometabolites
MAS Affected Bone SUV AUC(60-120min) - Blocked
Time frame: 120 minutes
To assess whether uptake in dysplastic bone reflects parent radioligand binding to the enzyme or merely accumulation of radiometabolites
2 secondary outcomes
MAS Affected Bone SUV AUC(60-120min) - for Baseline and Blocked Subjects With MAS
Time frame: 120 minutes
Normal Bone SUV AUC (60-120min) - for Healthy Controls
Time frame: 120 minutes after the start of the scan
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Robert B Innis, 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 1/2 study testing Brain PET Imaging with 11C Rolipram, Whole Body PET Baseline with 11C Rolipram and Whole Body PET Blocked with Roflumilast in people with Nervous System Disease, 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 8 inclusion and 22 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 19 Oct 2020. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Standard UptakeValue (SUV) Area Under the Curve (AUC) (30-120min) - Bladder (time frame: 120 minutes). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2020.