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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 is a Phase 2 study that has completed, run by Navidea Biopharmaceuticals. The registered enrollment target is 116 participants.
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)?
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03938636
The ClinicalTrials.gov registry entry for NCT03938636 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Navidea Biopharmaceuticals, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tc 99m tilmanocept is the first listed.
NCT03938636 reports 0 study locations.
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.
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