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NCT03232580 · ClinicalTrials.gov registry record · Phase 2
99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis
A Phase 2 study, sponsored by Advanced Accelerator Applications.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT03232580: Clinical Trial Phase 2 study, sponsored by Advanced Accelerator Applications.
NCT03232580 is a Phase 2 study that was terminated before completion, run by Advanced Accelerator Applications. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03232580, a Phase 2 study, was terminated before completion, sponsored by Advanced Accelerator Applications.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This single center, open-label, proof of concept (PoC) Phase II study aimed to assess the investigational imaging agent 99mTc-rhAnnexin V-128 in detecting spondyloarthritis (SpA) lesions. Overall, it was planned to recruit 20 adults with suspected or confirmed SpA. First, 5 patients were enrolled into a "proof of concept" phase, to assess the imaging potential of 99mTc-rhAnnexin V-128 in terms of imaging quality, disease-lesion radiotracer uptake and medical relevance. Based on these results the Data Monitoring Committee (DMC) was to decide whether to terminate the study or whether to continue and enroll the next 15 planned patients.
Primary Outcome
In order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results. Uptake compared with background (e.g. physiological liver uptake) were assessed for each affected area by nuclear medicine physicians using
Interventions
- DRUG rhAnnexin V-128
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-09-18 |
| Est. Completion | 2018-11-12 |
| Phase | Phase 2 |
Why NCT03232580 stopped before completion
NCT03232580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which rhAnnexin V-128 is the first listed.
NCT03232580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03232580 about?
NCT03232580 is a clinical study titled "99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis". This single center, open-label, proof of concept (PoC) Phase II study aimed to assess the investigational imaging agent 99mTc-rhAnnexin V-128 in detecting spondyloarthritis (SpA) lesions. Overall, it was planned to recruit 20 adults with suspected or confirmed SpA. First, 5 patients were enrolled i...
What is the current status of trial NCT03232580?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2017-09-18. Estimated completion is 2018-11-12.
What interventions are being tested in trial NCT03232580?
The interventions under investigation include: rhAnnexin V-128 (DRUG).
Who is sponsoring clinical trial NCT03232580?
This trial is sponsored by Advanced Accelerator Applications, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03232580's enrollment target sits among peer trials
5 2000th 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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