Ignite Creation Date:
2024-05-06 @ 4:19 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04947137
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-03-22
First Post:
2021-05-10
Brief Title:
Development of a Normative Database for Rheumatoid Arthritis RA Imaging With Tc99m Tilmanocept
Sponsor:
Navidea Biopharmaceuticals
Organization:
Navidea Biopharmaceuticals
Study Overview
Official Title:
Development of a Normative Database for Rheumatoid Arthritis RA Imaging With Tc99m Tilmanocept
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 study will establish a normative database of Tilmanocept Uptake Values TUVjoint in healthy controls age-matched to the RA population
Detailed Description:
This is a prospective open-label multicenter single-dose study designed to develop a normative database of TUVjoint in HCs and to assess the feasibility of qualitative and quantitative SPECTCT assessments in HCs and subjects with active RA
This study is stratified into 2 arms Arm 1 is comprised of HCs and Arm 2 is comprised of HCs and clinically diagnosed RA subjects on stable treatment
This study is stratified into 2 arms Arm 1 is comprised of HCs and Arm 2 is comprised of HCs and clinically diagnosed RA subjects on stable treatment
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