Ignite Creation Date:
2024-05-06 @ 1:07 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03938636
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2019-04-24
Brief Title:
Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value TUV on Tc 99m Tilmanocept Planar Imaging
Sponsor:
Navidea Biopharmaceuticals
Organization:
Navidea Biopharmaceuticals
Study Overview
Official Title:
Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value TUV on Tc 99m Tilmanocept Planar Imaging
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 andor test re-test ie 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
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 andor test re-test ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None