This study is a comparison of quantitative Tc 99m tilmanocept imaging with IHC analysis of CD206 expression in synovial tissue of RA subjects.
This is a Manocept Platform phase 2b, open-label, multi-center, multinational, non-randomized, single-dose study designed to assess the relationship between quantitative Tc 99m tilmanocept planar imaging and synovial histopathology in subjects clinically diagnosed with RA.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Attune Health
Beverly Hills, California, United States
Northwestern University
Chicago, Illinois, United States
Barts Hospital
London, England, United Kingdom
Royal Free Hospital
London, England, United Kingdom
Correlation Between Joint-specific Tilmanocept Uptake and CD206 Expression
The correlation between joint-specific tilmanocept uptake value (TUVjoint) and the number and area fraction of CD206 expression as determined by IHC assessment.
Time frame: Through study completion, up to 45 days
Correlation Between Joint-specific Tilmanocept Uptake and CD68 and CD163 Expression
The correlation between TUVjoint and the number and area fraction of CD68 and CD163 determined by IHC assessments.
Time frame: Through study completion, up to 45 days
Classification of Synovial Anatomic Pathotype by IHC Assessment
Classification of synovial anatomic pathology into * Lympho-myeloid * Diffuse myeloid * Pauci-immune fibroid types as a function of CD68, CD163, CD206, CD3, CD20, CD55, and TE7 expression determined by IHC assessments using a polytomous logistic regression model.
Time frame: Through study completion, up to 45 days
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