At a glance
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Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging
In Brief
A Phase 2 clinical trial evaluating Tc 99m tilmanocept for Rheumatoid Arthritis. Completed, enrolled 116 participants across 10 sites.
Detailed 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)?
Study Details
Timeline
Interventions
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.