NAV3-35

NAV3-35 is the identifier for a Phase 2b clinical trial conducted by Navidea Biopharmaceuticals to develop a normative database of healthy control images for Tc99m tilmanocept uptake in hands and wrists, supporting quantitative imaging assessment of rheumatoid arthritis (RA) joint inflammation. The trial includes two arms: Arm 1 acquires planar 2D images from 120 age- and sex-matched healthy volunteers injected with Tc99m tilmanocept to establish baseline Tilmanocept Uptake Values (TUVjoint); Arm 2 is a pilot for 3D SPECT/CT imaging in healthy subjects and RA patients. This database aims to enhance discrimination of RA-involved joints, predict treatment response, and train automated image analysis software for a planned Phase 3 RA imaging product.[2][4][5][9][10]