drugset / Trial / NCT03938636

Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging

NCT03938636

Phase 2 Completed 116 enrolled Navidea Biopharmaceuticals
Non-randomizedParallel-groupOpen-labelDiagnostic

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)?

Timeline

Start
2019-04-08
Primary completion
2021-02-08
Completion
2021-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Technetium Tc 99m Tilmanocept Diagnostic / imaging agent

Indications