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Completed Phase 2 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT03938636

Public ClinicalTrials.gov record NCT03938636. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:33 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03938636
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Navidea Biopharmaceuticals
Industry
Enrollment
116 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 7, 2019
Primary completion
Feb 7, 2021
Completion
Jun 29, 2021
Last update posted
Aug 23, 2023

2019 – 2021

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
10
Facility City State ZIP Site status
Imaging Endpoints Scottsdale Arizona 85258
Axis Clinical Trials Los Angeles California 90036
University of California San Francisco San Francisco California 94110
Innovation Medical Research Center Palmetto Bay Florida 33157
Physician Research Collaboration Lincoln Nebraska 68516
University Hospitals Cleveland Ohio 44106
Kettering Medical Center Kettering Ohio 45429
Central States Research Tulsa Oklahoma 74136
Altoona Center for Clinical Research Duncansville Pennsylvania 16635
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15213

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03938636, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 23, 2023 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03938636 live on ClinicalTrials.gov.

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