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NCT03424525 · ClinicalTrials.gov registry record · Phase 1
11C-Trimethoprim PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects
A Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03424525: Completed Phase 1 study, sponsored by University of Pennsylvania.
NCT03424525 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03424525, a Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Patients with suspected bacterial infection at the time screening are eligible for this study. Patients may participate in this study if they are at least 18 years of age, and most participants will be receiving care at the clinical practices of the University of Pennsylvania. Up to 30 subjects will participate in two different imaging cohorts. The Biodistribution cohort will include up to 5 patients referred from orthopedics who will undergo a series of vertex to mid-thigh (or feet if indicated) biodistribution \[11C\]trimethoprim PET/CT scans over a period of approximately 2 ½ hours. The Dynamic cohort will include up to 25 patients who will undergo approximately 60 minutes of dynamic scanning followed by up to 2 static skull base to mid-thigh (or feet if indicated) scans imaging post injection of \[11C\]trimethoprim. Some subjects who may be selected clinically to undergo surgical or antibiotic treatment may undergo a second therapy may also undergo an optional second \[11C\]trimethoprim PET/CT after the initiation of therapy to collect pilot data on the changes in \[11C\]trimethoprim biodistribution and uptake with therapy, the timing of this scan may vary depending on the type of treatment the patient is receiving. Patients will also undergo baseline lab tests complete blood count (CBC), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and blood cultures. If these tests are done as part of clinical standard of care they will not need to be repeated for this study.
Primary Outcome
The biodistribution which includes kinetics of uptake of \[11C\]TMP in human patients via PET/CT will be measured
Interventions
- DRUG 11C-Trimethoprim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2025-12-01 |
| Phase | Phase 1 |
What the finished NCT03424525 record still lists
NCT03424525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which 11C-Trimethoprim is the first listed.
NCT03424525 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03424525 about?
NCT03424525 is a clinical study titled "11C-Trimethoprim PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects". Patients with suspected bacterial infection at the time screening are eligible for this study. Patients may participate in this study if they are at least 18 years of age, and most participants will be receiving care at the clinical practices of the University of Pennsylvania. Up to 30 subjects will...
What is the current status of trial NCT03424525?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-02-01. Estimated completion is 2025-12-01.
What interventions are being tested in trial NCT03424525?
The interventions under investigation include: 11C-Trimethoprim (DRUG).
Who is sponsoring clinical trial NCT03424525?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03424525's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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