NCT03938636

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Navidea Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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)?

Detailed description

This trial is a prospective, open-label, multicenter, single and repeated-dose study designed to evaluate the reliability and sensitivity of TUV assessments in healthy control subjects and subjects with active RA. This study is stratified into 3 arms. The first 2 arms, consisting of \[1\] disease-free HCs and \[2\] clinically diagnosed RA subjects on stable treatment, respectively, are designed to evaluate the image re-image and/or test re-test (i.e., repeated dose) consistency of joint-specific and global TUVs across a variety of image acquisition intervals. The third arm consists of clinically-diagnosed subjects with active RA who are candidates for initiation of, or change to, a new anti-TNFα bDMARD therapy. This arm is designed to assess the efficacy of TUVglobal as an early predictor of response to the new anti-TNFα bDMARD therapy.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Tc 99m tilmanocept	Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.

Timeline

• Start date: 2019-04-08
• Primary completion: 2021-02-08
• Completion: 2021-06-30
• First posted: 2019-05-06
• Last updated: 2023-08-24
• Results posted: 2023-08-24

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study