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NCT01764919 · ClinicalTrials.gov registry record · Phase 2
[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection
A Phase 2 study, sponsored by BioMed Valley Discoveries.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT01764919: Clinical Trial Phase 2 study, sponsored by BioMed Valley Discoveries.
NCT01764919 is a Phase 2 study that was terminated before completion, run by BioMed Valley Discoveries. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01764919, a Phase 2 study, was terminated before completion, sponsored by BioMed Valley Discoveries.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
This protocol will evaluate the sensitivity and specificity of \[124I\]FIAU as a diagnostic imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.
Primary Outcome
A bone biopsy was obtained through a noninfected area and submitted for histology and microbiologic culture. Cultures were also to be obtained by biopsy after debridement of the ulcer from a clean base. Subjects were dosed with \[124I\]FIAU. PET-CT scanning were performed. All PET, PET-CT, and CT images, both attenuation corrected and uncorrected, were to be evaluated centrally and independently. Results from the bone biopsies were not available to the central reader of the PET-CT images. The se
Interventions
- RADIATION [124I]FIAU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-02 |
| Phase | Phase 2 |
Why NCT01764919 stopped before completion
NCT01764919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which [124I]FIAU is the first listed.
NCT01764919 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01764919 about?
NCT01764919 is a clinical study titled "[124I]FIAU PET-CT Scanning in Diagnosing Osteomyelitis in Patients With Diabetic Foot Infection". This protocol will evaluate the sensitivity and specificity of \[124I\]FIAU as a diagnostic imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.
What is the current status of trial NCT01764919?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2013-04. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01764919?
The interventions under investigation include: [124I]FIAU (RADIATION).
Who is sponsoring clinical trial NCT01764919?
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 NCT01764919's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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