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NCT01337466 · ClinicalTrials.gov registry record · Phase 1
Biodistribution and Dosimetry Evaluation of [124I]FIAU
A Phase 1 study, sponsored by BioMed Valley Discoveries.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01337466: Completed Phase 1 study, sponsored by BioMed Valley Discoveries.
NCT01337466 is a Phase 1 study that has completed, run by BioMed Valley Discoveries. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01337466, a Phase 1 study, has completed, sponsored by BioMed Valley Discoveries.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This protocol will evaluate the biodistribution and dosimetry of \[124I\]FIAU in both healthy volunteers and patients with prosthetic joint infections. This pilot study will also investigate the safety and tolerability of \[124I\]FIAU.
Primary Outcome
Subjects will be dosed with \[124I\]FIAU at Time 0 on Day 0, and a PET-CT scan will be conducted immediately after the injection. Imaging will be repeated at 2 hours, 4 hours, 6 hours, 24 hours, 48 hours, and 72 hours after dosing. All images generated will be reviewed for biodistribution and dosimetry.
Interventions
- RADIATION [124I]FIAU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT01337466 record still lists
NCT01337466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which [124I]FIAU is the first listed.
NCT01337466 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01337466 about?
NCT01337466 is a clinical study titled "Biodistribution and Dosimetry Evaluation of [124I]FIAU". This protocol will evaluate the biodistribution and dosimetry of \[124I\]FIAU in both healthy volunteers and patients with prosthetic joint infections. This pilot study will also investigate the safety and tolerability of \[124I\]FIAU.
What is the current status of trial NCT01337466?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-12. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01337466?
The interventions under investigation include: [124I]FIAU (RADIATION).
Who is sponsoring clinical trial NCT01337466?
This trial is sponsored by BioMed Valley Discoveries, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01337466's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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