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NCT02743377 · ClinicalTrials.gov registry record · Phase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of McCune-Albright Syndrome
A Phase 1 study of Nervous System Disease, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02743377 is a Phase 1 study of Nervous System Disease that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 16 participants, below the 322-participant average among 3 other Nervous System Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02743377, a Phase 1 study of Nervous System Disease, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Conditions Studied
Interventions
- OTHER Brain PET Imaging with 11C Rolipram
- DRUG Whole Body PET Baseline with 11C Rolipram
- DRUG Whole Body PET Blocked with Roflumilast
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-04-04 |
| Est. Completion | 2020-05-19 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02743377
The ClinicalTrials.gov registry entry for NCT02743377 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 322-participant average among 3 other Nervous System Disease trials with a reported enrollment target (95% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Nervous System Disease appearing as the primary indexed condition, and to 3 interventions - of which Brain PET Imaging with 11C Rolipram is the first listed.
NCT02743377 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02743377 about?
NCT02743377 is a clinical study titled "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 (PDE...
What is the current status of trial NCT02743377?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-04-04. Estimated completion is 2020-05-19.
What conditions does trial NCT02743377 study?
This clinical trial studies the following conditions: Nervous System Disease.
What interventions are being tested in trial NCT02743377?
The interventions under investigation include: Brain PET Imaging with 11C Rolipram (OTHER), Whole Body PET Baseline with 11C Rolipram (DRUG), Whole Body PET Blocked with Roflumilast (DRUG).
Who is sponsoring clinical trial NCT02743377?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02743377 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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