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NCT03938636 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging
A Phase 2 study, sponsored by Navidea Biopharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
NCT03938636: Completed Phase 2 study, sponsored by Navidea Biopharmaceuticals.
NCT03938636 is a Phase 2 study that has completed, run by Navidea Biopharmaceuticals. The registered enrollment target is 116 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03938636, a Phase 2 study, has completed, sponsored by Navidea Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
Study Summary
This clinical trial will look at scans of the hands and wrists taken from healthy control subjects (HCs) and from subjects with rheumatoid arthritis (RA). Before each scan, subjects will be given an injection of Tc 99m tilmanocept to help the scan identify inflammation in the hand and wrist joints, which can be a part of the RA disease. Data from the scans will be used to calculate a number referred to as tilmanocept uptake value (or TUV) that is a measure of how much Tc 99m tilmanocept has located in the joints. The questions this trial aims to answer are: * How consistent are the scan results (TUVs) when the scans are repeated over time? * What are normal TUVs in healthy people? This will help define abnormally high values in people with RA. * Are TUVs calculated early after a person starts a new drug to treat RA able to predict whether that person will have a good response to the drug later on (after it has had time to take full effect several weeks later)?
Primary Outcome
The camera-specific precision of TUVjoint in subjects with active RA and Healthy Controls (HCs), which is described as the Root Mean Square Difference (RMSD) between the 15-minute planar images (referred to as A and B images at 60 and 180 minutes). The RMSD is calculated as the square root of the mean squared deviation from zero.
Interventions
- DRUG Tc 99m tilmanocept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2019-04-08 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 2 |
What the finished NCT03938636 record still lists
NCT03938636 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 1 intervention - of which Tc 99m tilmanocept is the first listed.
NCT03938636 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03938636 about?
NCT03938636 is a clinical study titled "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging". This clinical trial will look at scans of the hands and wrists taken from healthy control subjects (HCs) and from subjects with rheumatoid arthritis (RA). Before each scan, subjects will be given an injection of Tc 99m tilmanocept to help the scan identify inflammation in the hand and wrist joints, ...
What is the current status of trial NCT03938636?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2019-04-08. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT03938636?
The interventions under investigation include: Tc 99m tilmanocept (DRUG).
Who is sponsoring clinical trial NCT03938636?
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 NCT03938636's enrollment target sits among peer trials
116 623rd of 2000 higher than 1,375 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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