This study will establish a normative database of Tilmanocept Uptake Values (TUVjoint) in healthy controls age-matched to the RA population.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
134
Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
San Marcus Research Clinic
Miami Lakes, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
Kettering Medical Center
Kettering, Ohio, United States
Essential Medical Research
Tulsa, Oklahoma, United States
Normal Limits of TUVjoint in Healthy Subjects
The normal limits of TUVjoint (on a per joint basis) in HC subjects, which are defined as the 5 and 95 percentiles of TUVjoint of bilateral joints (i.e., bilateral wrists, metacarpophalangeal joint \[MCPs\], proximal interphalangeal \[PIPs\]).
Time frame: Up to 39 days
Qualitative Evaluation of SPECT/CT for Tilmanocept Localization
Presence/absence of tilmanocept localization in the hands and wrists will be summarized with frequency counts and percentages by reader and joint.
Time frame: Up to 39 days
Normal Distribution of TUVjoint
Applicability of the Normal (Gaussian) distribution to TUVjoint data as assessed by normal quantile plots provided per joint and reader and p-value for the Shapiro-Wilk test of Normality.
Time frame: Up to 39 days
Quantitative Evaluation of SPECT/CT
Determination of joint-specific standardized uptake value (SUV) from SPECT/CT imaging within synovial spaces of the bilateral hands and wrists in HCs and RA subjects.
Time frame: Up to 39 days
Planar and SPECT/CT Comparison
Assessment of the predictive value of planar scans for SPECT/CT scans.
Time frame: Up to 39 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Sun Research Institute
San Antonio, Texas, United States
Tranquility Research
Webster, Texas, United States