39
Participants
Start Date
January 31, 2017
Primary Completion Date
June 30, 2018
Study Completion Date
June 30, 2018
Tc99m-tilmanocept
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
SPECT Imaging (60 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.
SPECT Imaging (180 Minutes post-injection)
Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.
Whole body planar SPECT imaging (15 Minutes post-injection)
Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 15 minutes post-injection for dosimetry.
Whole body planar SPECT imaging (60 Minutes post-injection)
Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 60 minutes post-injection for dosimetry.
Whole body planar SPECT imaging (180 Minutes post-injection)
Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 180 minutes post-injection for dosimetry.
Whole body planar SPECT imaging (18-20 Hours post-injection)
Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 18-20 Hours post-injection for dosimetry.
Blood Collection for PK Testing (15 Mins Before Injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis within 15 minutes prior to administration of Tc 99m tilmanocept
Blood Collection for PK Testing (after injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis immediately following administration of Tc 99m tilmanocept (00:00)
Blood Collection for PK Testing (15 minutes post injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 15 ± 5 minutes post injection of Tc 99m tilmanocept
Blood Collection for PK Testing (60 minutes post injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 60 ± 15 minutes post injection of Tc 99m tilmanocept
Blood Collection for PK Testing (180 minutes post injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 180 ± 15 minutes post injection of Tc 99m tilmanocept
Blood Collection for PK Testing (18-20 hours post injection)
Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 18-20 hours post injection of Tc 99m tilmanocept
Planar Image with both Hands in Field of View
Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.
Kettering Medical Center, Kettering
Lead Sponsor
Navidea Biopharmaceuticals
INDUSTRY