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NCT02683421 · ClinicalTrials.gov registry record · Phase 1
Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging
A Phase 1 study, sponsored by Navidea Biopharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02683421: Completed Phase 1 study, sponsored by Navidea Biopharmaceuticals.
NCT02683421 is a Phase 1 study that has completed, run by Navidea Biopharmaceuticals. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02683421, a Phase 1 study, has completed, sponsored by Navidea Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Determine the localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with active RA and concordance with clinical symptomology.
Primary Outcome
The primary endpoint was to compare the cumulative total of anatomical zones of active RA (which were clinically defined by a swollen/tender classification during the DAS28 joint count assessment performed at baseline) with Tc 99m tilmanocept localization observed at 2-3 hours and at 4-6 hours after administration on Day 1. Tc 99m tilmanocept localization is defined by accumulation of radioactivity at an intensity greater than background, which was qualitatively determined by the central reader'
Interventions
- DRUG Tilmanocept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2016-07 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
What the finished NCT02683421 record still lists
NCT02683421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Tilmanocept is the first listed.
NCT02683421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02683421 about?
NCT02683421 is a clinical study titled "Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging". Determine the localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with active RA and concordance with clinical symptomology.
What is the current status of trial NCT02683421?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2016-07. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02683421?
The interventions under investigation include: Tilmanocept (DRUG).
Who is sponsoring clinical trial NCT02683421?
This trial is sponsored by Navidea Biopharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02683421's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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