Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a prospective, open-label, multicenter, single and repeat-dose study designed to evaluate the reliability and sensitivity of TUV assessments in healthy controls and subjects with active RA.Masking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a Manocept Platform prospective, open-label, multicenter, single and repeat-dose study designed to evaluate the reliability and sensitivity of TUV assessments in HCs and subjects with active RA. This study is stratified into 3 arms. The first 2 arms, comprised of [1] disease-free HCs and [2]...
This is a Manocept Platform prospective, open-label, multicenter, single and repeat-dose study designed to evaluate the reliability and sensitivity of TUV assessments in HCs and subjects with active RA. This study is stratified into 3 arms. The first 2 arms, comprised of [1] disease-free HCs and [2] clinically diagnosed RA subjects on stable treatment. The third arm is designed to assess the efficacy of TUV global in clinically diagnosed subjects with active RA..
Tracking Information
- NCT #
- NCT03938636
- Collaborators
- Not Provided
- Investigators
- Study Director: Michael Blue, MD Navidea Biopharmaceuticals
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