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NCT03912428 · ClinicalTrials.gov registry record · Phase 1
Novel PET Radioligand as an Inflammatory Biomarker in Musculoskeletal Conditions
A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT03912428: Clinical Trial Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
NCT03912428 is a Phase 1 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03912428, a Phase 1 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
Background: Inflammation plays a significant role in various disorders that involve neurodegeneration or autoimmune reaction as one of their mechanisms. PET scans can help detect inflammation. Two new drugs may create better PET images. Objective: \- To see if the drug \[11C\]MC1 can help image inflammation. Eligibility: * People age 18 and older with rheumatoid arthritis or idiopathic inflammatory myopathy (IIM). * Healthy volunteers enrolled in protocol 01-M-0254 or 17-M-0181 are also needed. Design: * Healthy participants will be screened under protocol 01-M-0254 or 17-M-0181. * Participants with arthritis or IIM will have a screening visit. This will include: * Medical history * Physical exam * Blood and urine tests * Possible CT or X-ray: A machine will take pictures of the body. * Healthy participants will have 1 or 2 visits. They may have urine tests. They may take the drug celecoxib by mouth. They will have a PET scan. A small amount of one or both study drugs will be injected through a catheter: A needle will guide a thin plastic tube into an arm vein. Another catheter will draw blood. They will like on a bed that slides into a machine. Their vital signs and heart activity will be measured. * Participants with arthritis will have up to 2 visits after screening. They may take celecoxib and have PET scans. * Participants with IIM will have up to 3 visits after screening. At 1 or 2 visits, they will take celecoxib and have PET scans. They will have 1 visit where they have an MRI: They will lie on a table that slides into a machine. The machine takes pictures of the body.
Primary Outcome
Participant received whole body PET/CT scan and radioligand uptake of \[11C\]MC1 in selected body regions of interest was quantified as a Standardized Uptake Value (SUV) using the Siemens Biograph Micro-Computed Tomography (mCT) with an injected dose of 9 mCi. Organ dosimetry was measured as dose per organ in Roentgen Equivalent Man (rem), which is absorbed dose times an organ-specific quality factor.
Interventions
- DRUG Celecoxib
- DRUG 11C-MC1
- DRUG [11C]ER176
- DIAGNOSTIC_TEST Positron Emission Tomography (PET)/computed tomography (CT) Scan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-06-14 |
| Est. Completion | 2024-06-14 |
| Phase | Phase 1 |
Why NCT03912428 stopped before completion
NCT03912428 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 4 interventions - of which Celecoxib is the first listed.
NCT03912428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03912428 about?
NCT03912428 is a clinical study titled "Novel PET Radioligand as an Inflammatory Biomarker in Musculoskeletal Conditions". Background: Inflammation plays a significant role in various disorders that involve neurodegeneration or autoimmune reaction as one of their mechanisms. PET scans can help detect inflammation. Two new drugs may create better PET images. Objective: \- To see if the drug \[11C\]MC1 can help image i...
What is the current status of trial NCT03912428?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2019-06-14. Estimated completion is 2024-06-14.
What interventions are being tested in trial NCT03912428?
The interventions under investigation include: Celecoxib (DRUG), 11C-MC1 (DRUG), [11C]ER176 (DRUG), Positron Emission Tomography (PET)/computed tomography (CT) Scan (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03912428?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03912428's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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