CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 116 enrolled
Drug / intervention
Tc 99m tilmanoceptdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03938636
NCT03938636Phase 2Completed

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

Navidea Biopharmaceuticals·interventional·Posted May 6, 2019·Updated Aug 24, 2023

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 6, 2019
Enrollment StartApr 8, 2019
Primary CompletionFeb 8, 2021
Study CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.2 years ago

Interventions

Tc 99m tilmanoceptdrug

Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.