NCT04947137

Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Navidea Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 SPECT/CT 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Tc99m tilmanocept	Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.

Timeline

• Start date: 2021-05-27
• Primary completion: 2022-01-21
• Completion: 2022-01-21
• First posted: 2021-07-01
• Last updated: 2025-01-08
• Results posted: 2025-01-08

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study