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NCT03324646 · ClinicalTrials.gov registry record
Evaluation of a Novel PET Radioligand to Image Cyclooxygenase-1 (COX-1)
A clinical trial, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 52
- Enrollment target
NCT03324646: Completed study, sponsored by National Institute of Mental Health (NIMH).
NCT03324646 is a clinical trial that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03324646 has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 52 participants
- Enrollment target
Study Summary
Background: A radioligand is a radioactive substance that is used to diagnose diseases. A new ligand is called \[11C\]PS13. This has a small amount of radioactivity that can be detected by a positron emission tomography (PET) scan. If this ligand works well in this study, researchers may be able to use it to better understand and diagnose brain disorders. Objectives: To evaluate if \[11C\]PS13 can measure its receptor, which is involved in inflammation. To see if researchers get the same results when scanning a person twice. Eligibility: Healthy people ages 18 and older who are in Protocol 01-M-0254. Design: This study requires three visits of 2-5 hours each. Participants will have 2 PET scans with \[11C\]PS13. A needle will guide a small plastic tube (catheter) into an arm vein. The needle will be removed, leaving only the catheter in the vein. The ligand will be injected through the catheter. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. Participants will wear a molded a plastic mask that fits the head. Another catheter will be put into an artery at the wrist or elbow area. Vital signs will be monitored during the PET scan. Participants will have a test during the PET scan to monitor heart function. Participants will have blood and urine tests. Participants will have 1 magnetic resonance imaging (MRI) scan. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder.
Primary Outcome
For whole body imaging, organ uptake will be quantified as a Standardized Uptake Value (SUV), which normalizes for injected activity and body weight. Blockade by aspirin, ketoprofen, and celecoxib will be expressed as a percentage of the baseline scan in each subject and plotted relative to the plasma concentration of the drug at time of the PET scan. For dedicated brain imaging, uptake will be quantified as distribution volume (VT) calculated with compartmental modeling and serial concentration
Interventions
- DRUG [11C]PS13
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2017-10-03 |
| Est. Completion | 2024-01-30 |
What the finished NCT03324646 record still lists
NCT03324646 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which [11C]PS13 is the first listed.
NCT03324646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03324646 about?
NCT03324646 is a clinical study titled "Evaluation of a Novel PET Radioligand to Image Cyclooxygenase-1 (COX-1)". Background: A radioligand is a radioactive substance that is used to diagnose diseases. A new ligand is called \[11C\]PS13. This has a small amount of radioactivity that can be detected by a positron emission tomography (PET) scan. If this ligand works well in this study, researchers may be able to...
What is the current status of trial NCT03324646?
This trial is currently completed. The enrollment target is 52 participants. The study started on 2017-10-03. Estimated completion is 2024-01-30.
What interventions are being tested in trial NCT03324646?
The interventions under investigation include: [11C]PS13 (DRUG).
Who is sponsoring clinical trial NCT03324646?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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