Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA

An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection and Skeletal Joint Imaging With SPECT in Subjects With Active Rheumatoid Arthritis (RA) and Healthy Controls

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02865434

Enrollment

Registered

2016-08-12

Start date

2017-01-31

Completion date

2018-06-30

Last updated

2021-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Brief summary

Prospective, open-label, multicenter, dose escalation, safety with pharmacokinetics (PK) and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging.

Detailed description

A Manocept Platform prospective, open-label, multicenter, dose escalation, safety with PK and dosimetry study of injected Tc 99m tilmanocept in the detection of and assessment of localization to skeletal joints in subjects with and without active RA by SPECT imaging. All subjects will receive IV administration at one of 3 mass doses: 50 µg, 200 µg, or 400 µg. Within each mass dose group, subjects will receive Tc 99m tilmanocept labeled with one of 3 radiolabel doses: 1 mCi, 5 mCi, or 10 mCi. All subjects will have a whole body planar SPECT scan. Subjects enrolled in Groups 1-9 will receive a whole body and planar hands scan followed by SPECT/CT scans on areas of interest post injection at 60 minutes ± 15 minutes and 180 minutes ± 15 minutes. Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed at 4 specified time points post injection: 15 ± 5 minutes, 60 ± 15 minutes, 180 ± 15 minutes and 18-20 hours. Planar hand scans will be collected at 60 ± 15 minutes and 180 ± 15 minutes post-injection. PK blood sampling will be performed before injection (within 15 minutes), immediately following injection (within 5 minutes) and at each scanning timepoint. Dosimetry tests will be performed at each scanning timepoint. PK of urine will be assessed through counts of the bladder wall obtained from cumulative quantitative planar imaging from radiation dosimetry.

Interventions

DRUGTc99m-tilmanocept

Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.

PROCEDURESPECT 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.

PROCEDURESPECT 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.

PROCEDUREWhole 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.

PROCEDUREWhole 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.

PROCEDUREWhole 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.

PROCEDUREWhole 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.

PROCEDUREBlood 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

PROCEDUREBlood 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)

PROCEDUREBlood 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

PROCEDUREBlood 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

PROCEDUREBlood 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

PROCEDUREBlood 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

PROCEDUREPlanar 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

ALL SUBJECTS: * The subject has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) authorization before the initiation of any study-related procedures. * Has a negative urine drug screening for illicit or unprescribed drugs suggestive of drug abuse. * All subjects shall be ≥18 years of age at the time of consent. CONTROL SUBJECTS: * The subject is deemed to be clinically free of any inflammatory disease (s) and has not experienced joint pain for at least 4 weeks prior to the consent date. ACTIVE RHEUMATOID ARTHRITIS SUBJECTS: * The subject has moderate to severe RA as determined by the 2010 ACR/EULAR (score of ≥ 6/10). * The subject has a DAS28 of ≥ 3.2 (includes the Erythrocyte Sedimentation Rate \[ESR\] test and Visual Analog Scale \[VAS\]) . * If the subject is receiving methotrexate, they have been at a stable dose for \> 4 weeks prior to the Baseline Visit 2 (Day 1). * If the subject is receiving biologic therapy, they have been at a stable dose \> 8 weeks prior to the Baseline Visit 2 (Day 1). * If the subject is receiving NSAIDS or oral corticosteroids, the dose has been at a stable dose for \> 4 weeks prior to the Baseline Visit 2 (Day 1). The corticosteroid dose should be ≤ 10mg/day of prednisone or an equivalent steroid dose.

Exclusion criteria

* The subject is pregnant or lactating. * The subject size or weight is not compatible with imaging per the investigator. * The subject has had or is currently receiving radiation therapy or chemotherapy for a condition other than rheumatoid arthritis. * The subject has renal insufficiency as demonstrated by serum creatinine clearance of \< 60 mL/min. * The subject has hepatic insufficiency as demonstrated by ALT or AST greater than two times the upper limit of normal. * The subject has a chronic or persistent infection or has any condition that would, in the opinion of the examining physician, preclude their participation. * The subject has a known allergy to or has had an adverse reaction to dextran exposure. * The subject has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration. * The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Adverse Drug Reaction	From Enrollment to termination, up to 53 days	Number of participants that experienced pharmacologic activity or ADR in each dose group.

Secondary

Measure	Time frame	Description
Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Whole-body planar scan at 60 ± 15 and 180 ± 15 minutes post Tc 99m tilmanocept administration with a duration of approximately 25 to 30 minutes at each timepoint.	Per joint (clinically RA-identified) joint localization rate of Tc 99m tilmanocept is defined as the number of localized joints per number of joints from subjects in the analysis population Groups 1-9 using SPECT imaging.
Concordance	Qualitative (i.e., visual) assessments of planar images were acquired at the 60 ± 15-minute and 180 ± 15-minute timepoints in Groups 1-9.	Concordance is defined as the relationship or the presence of Tc99m localization in anatomical areas of active RA defined by clinical symptomology (defined as joint swelling (SJC) and/or tenderness (TJC) during the screening DAS28 evaluation).
Localization Intensity	Post-injection imaging at 60±15 and 180±15 min	Localization intensity is defined as the presence of Tc99m in each DAS28 joint and is output in tilmanocept uptake value (TUV) units, as computed using the following equation: 〖TUV〗=ROI/BRAIN×100 where ROI = decay-corrected avg voxel intensity of the joint ROI and BRAIN =decay-corrected avg voxel intensity of the brain RR
Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Imaging taken 60 ± 15 min and 180 ± 15 min post-injection	Per subject localization rate of Tc 99m tilmanocept in areas other than RA is defined as the number of subjects with at least one localized DAS28 joint per number of subjects in the analysis population.
Maximum Observed Concentration (Cmax)	15 minutes prior to administration. Immediately after administration. 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration	Maximum observed concentration (Cmax) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.
Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	For Groups 1-9, 60 ± 15 min or 180 ± 15 minute post injection planar and SPECT/CT images are used	Tc 99m Tilmanocept localization is defined as the visually (i.e., qualitatively) determined binary categorization of Tc 99m tilmanocept activity in a given DAS28 joint. The purpose of the visual assessments is to obtain dichotomized classifications of tracer uptake (herein referenced as 'localization') on planar images. Per subject localization rate is the number of subjects with at least one localized DAS28 joint per number of subjects in the analysis population.
Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measureable Concentration (AUC0-t)	Hour 0 to hour 18-20, with time points immediately post injection, 0.25 hr, 1 hr, 3 hr and 18-20 hr after injection	Area under the concentration-time curve (AUC) from Hour 0 to the last measureable concentration (18 to 20 hours) (AUC0-t) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.
AUC Extrapolated to Infinity	15 mins prior to administration • Immediately after administration • 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration	AUC extrapolated to infinity will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.
Apparent Terminal Elimination Rate Constant (Z)	15 mins prior to administration • Immediately after administration • 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration	Apparent terminal elimination rate constant (Z) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.
Apparent Terminal Elimination Half-life (t1/2)	15 mins prior to administration • Immediately after administration • 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration	Apparent terminal elimination half-life (t1/2) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.
Radiation Dosimetry of Tc 99m Tilmanocept	Planar images were taken 15 ± 5 minutes, 60 ± 5 minutes, 180 ± 5 minutes, 18 to 20 hours after Tc 99m tilmanocept administration and processed in accordance with the NAV3-21 protocol endpoints using established dosimetry software.	Mean total radiation dose per organ (mSv/MBq) in HC females, HC males, females with active RA, and males with active RA. Results were obtained at the subject level from Hybrid Dosimetry™ Version 2.8.3 and OLINDA/EXM® Version 2.1RC93 in accordance with NAV3-21 Protocol Amendment 6. The Hybrid Dosimetry™ function provides an efficient way to generate kinetic data for selected organs via regions of interest (ROI) drawing. From this data, residence times are calculated and transferred to OLINDA/EXM®, which generates absorbed dose tables using the MIRD methodology.
Time to Cmax (Tmax)	Radioactivity was quantitated at each time point -15 mins prior to administration• Immediately after administration •15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post admi	Time to Cmax (tmax) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Group 1 (RA) Group 1 will receive 50 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m as a single IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). 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. 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.	3
Group 2 (RA) Group 2 will receive 200 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). 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. 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.	3
Group 3 (RA) Group 3 will receive 400 µg Tc99m-tilmanocept radiolabeled with 10 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). 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. 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.	3
Group 4 (RA) Group 4 will receive 50 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). 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. 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.	3
Group 5 (RA) Group 5 will receive 200 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). 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. 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.	3
Group 6 (RA) Group 6 will receive 400 µg Tc99m-tilmanocept radiolabeled with 5 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). 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. 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.	3
Group 7 (RA) Group 7 will receive 50 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). 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. 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.	3
Group 8 (RA) Group 8 will receive 200 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). 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. 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.	3
Group 9 (RA) Group 9 will receive 400 µg Tc99m-tilmanocept radiolabeled with 1 mCi Tc99m via IV injection. Subjects will receive SPECT Imaging (60 Minutes post-injection) and SPECT Imaging (180 Minutes post-injection). 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. 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.	3
Group 10 (Healthy Controls) Group 10 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection).	6
Group 11 (RA) Group 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m the MTD via IV injection. Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface. Whole body planar SPECT imaging (15 Minutes post-injection), Whole body planar SPECT imaging (60 minutes post-injection), Whole body planar SPECT imaging (180 minutes post-injection), and Whole body planar SPECT imaging (18-20 hours post-injection). Planar Image with both Hands in Field of View (60 minutes and 180 minutes post-injection). Blood Collection for PK Testing (15 Mins Before Injection), Blood Collection for PK Testing (after Injection), Blood Collection for PK Testing (15 minutes post injection), Blood Collection for PK Testing (60 minutes post injection), Blood Collection for PK Testing (180 minutes post injection), and Blood Collection for PK Testing (18-20 hours post injection).	6
Total	39

Baseline characteristics

Characteristic	Group 1 (RA)	Group 2 (RA)	Group 3 (RA)	Group 4 (RA)	Group 5 (RA)	Group 6 (RA)	Group 7 (RA)	Group 8 (RA)	Group 9 (RA)	Group 10 (Healthy Controls)	Group 11 (RA)	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	6 Participants	6 Participants	39 Participants
Age, Continuous	55.3 years STANDARD_DEVIATION 8.14	58.7 years STANDARD_DEVIATION 4.73	55.0 years STANDARD_DEVIATION 11.16	46.3 years STANDARD_DEVIATION 9.87	50.7 years STANDARD_DEVIATION 12.74	52.0 years STANDARD_DEVIATION 12.53	53.3 years STANDARD_DEVIATION 5.69	56.3 years STANDARD_DEVIATION 8.14	58.0 years STANDARD_DEVIATION 3	32.0 years STANDARD_DEVIATION 12.55	55.0 years STANDARD_DEVIATION 11.16	54.2 years STANDARD_DEVIATION 8.99
BMI	24.4 kg/m^2 STANDARD_DEVIATION 7.4	29.8 kg/m^2 STANDARD_DEVIATION 3.1	33.5 kg/m^2 STANDARD_DEVIATION 7.5	29.5 kg/m^2 STANDARD_DEVIATION 8.47	39.2 kg/m^2 STANDARD_DEVIATION 11.75	39.3 kg/m^2 STANDARD_DEVIATION 8.8	29.2 kg/m^2 STANDARD_DEVIATION 4.76	34.5 kg/m^2 STANDARD_DEVIATION 4.62	33.5 kg/m^2 STANDARD_DEVIATION 6.37	27.3 kg/m^2 STANDARD_DEVIATION 7.74	33.5 kg/m^2 STANDARD_DEVIATION 7.5	32.7 kg/m^2 STANDARD_DEVIATION 7.72
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	2 Participants	3 Participants	3 Participants	3 Participants	6 Participants	4 Participants	36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	4 Participants
Race (NIH/OMB) More than one race	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants	9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	2 Participants	2 Participants	2 Participants	3 Participants	3 Participants	1 Participants	2 Participants	2 Participants	1 Participants	3 Participants	5 Participants	26 Participants
Region of Enrollment United States	3 participants	3 participants	3 participants	3 participants	3 participants	3 participants	3 participants	3 participants	3 participants	6 participants	6 participants	39 participants
Sex: Female, Male Female	2 Participants	2 Participants	3 Participants	2 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	30 Participants
Sex: Female, Male Male	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	3 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk
deaths Total, all-cause mortality	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 6	0 / 6
other Total, other adverse events	3 / 3	0 / 3	0 / 3	0 / 3	0 / 3	1 / 3	0 / 3	1 / 3	0 / 3	2 / 6	1 / 6
serious Total, serious adverse events	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 3	0 / 6	0 / 6

Outcome results

Primary

Incidence of Adverse Drug Reaction

Number of participants that experienced pharmacologic activity or ADR in each dose group.

Time frame: From Enrollment to termination, up to 53 days

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Group 1 (RA)	Incidence of Adverse Drug Reaction	3 Participants
Group 2 (RA)	Incidence of Adverse Drug Reaction	3 Participants
Group 3 (RA)	Incidence of Adverse Drug Reaction	3 Participants
Group 4 (RA)	Incidence of Adverse Drug Reaction	3 Participants
Group 5 (RA)	Incidence of Adverse Drug Reaction	3 Participants
Group 6 (RA)	Incidence of Adverse Drug Reaction	3 Participants
Group 7 (RA)	Incidence of Adverse Drug Reaction	3 Participants
Group 8 (RA)	Incidence of Adverse Drug Reaction	3 Participants
Group 9 (RA)	Incidence of Adverse Drug Reaction	3 Participants
Group 10 (Healthy Controls)	Incidence of Adverse Drug Reaction	6 Participants
Group 11 (RA)	Incidence of Adverse Drug Reaction	6 Participants

Secondary

Apparent Terminal Elimination Half-life (t1/2)

Apparent terminal elimination half-life (t1/2) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.

Time frame: 15 mins prior to administration • Immediately after administration • 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration

Population: Groups 10 and 11.

Arm	Measure	Value (MEAN)
Group 10 (Healthy Controls)	Apparent Terminal Elimination Half-life (t1/2)	759.0 minutes
Group 11 (RA)	Apparent Terminal Elimination Half-life (t1/2)	719.1 minutes

Secondary

Apparent Terminal Elimination Rate Constant (Z)

Apparent terminal elimination rate constant (Z) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.

Population: Groups 10 and 11 only.

Arm	Measure	Value (MEAN)
Group 10 (Healthy Controls)	Apparent Terminal Elimination Rate Constant (Z)	0.00094 1/minute
Group 11 (RA)	Apparent Terminal Elimination Rate Constant (Z)	0.00100 1/minute

Secondary

Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measureable Concentration (AUC0-t)

Area under the concentration-time curve (AUC) from Hour 0 to the last measureable concentration (18 to 20 hours) (AUC0-t) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.

Time frame: Hour 0 to hour 18-20, with time points immediately post injection, 0.25 hr, 1 hr, 3 hr and 18-20 hr after injection

Population: Groups 10 and 11

Arm	Measure	Group	Value (MEAN)
Group 10 (Healthy Controls)	Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measureable Concentration (AUC0-t)	Whole blood AUC	235258.0 min*nCi/mL
Group 10 (Healthy Controls)	Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measureable Concentration (AUC0-t)	Urine AUC	1468788.9 min*nCi/mL
Group 11 (RA)	Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measureable Concentration (AUC0-t)	Whole blood AUC	268110.7 min*nCi/mL
Group 11 (RA)	Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measureable Concentration (AUC0-t)	Urine AUC	1384642.0 min*nCi/mL

Secondary

AUC Extrapolated to Infinity

AUC extrapolated to infinity will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.

Population: Groups 10 and 11 only.

Arm	Measure	Value (MEAN)
Group 10 (Healthy Controls)	AUC Extrapolated to Infinity	370580.1 min*nCi/mL
Group 11 (RA)	AUC Extrapolated to Infinity	396026.4 min*nCi/mL

Secondary

Concordance

Concordance is defined as the relationship or the presence of Tc99m localization in anatomical areas of active RA defined by clinical symptomology (defined as joint swelling (SJC) and/or tenderness (TJC) during the screening DAS28 evaluation).

Time frame: Qualitative (i.e., visual) assessments of planar images were acquired at the 60 ± 15-minute and 180 ± 15-minute timepoints in Groups 1-9.

Population: Groups 10 \& 11 were not included in the population these endpoints were evaluated for.

Arm	Measure	Group	Value (COUNT_OF_UNITS)
Group 1 (RA)	Concordance	Concordance at 3 hr	38 Joint
Group 1 (RA)	Concordance	Concordance at 1 hr	21 Joint
Group 2 (RA)	Concordance	Concordance at 1 hr	32 Joint
Group 2 (RA)	Concordance	Concordance at 3 hr	32 Joint
Group 3 (RA)	Concordance	Concordance at 1 hr	17 Joint
Group 3 (RA)	Concordance	Concordance at 3 hr	27 Joint
Group 4 (RA)	Concordance	Concordance at 1 hr	39 Joint
Group 4 (RA)	Concordance	Concordance at 3 hr	39 Joint
Group 5 (RA)	Concordance	Concordance at 1 hr	31 Joint
Group 5 (RA)	Concordance	Concordance at 3 hr	31 Joint
Group 6 (RA)	Concordance	Concordance at 1 hr	29 Joint
Group 6 (RA)	Concordance	Concordance at 3 hr	31 Joint
Group 7 (RA)	Concordance	Concordance at 3 hr	37 Joint
Group 7 (RA)	Concordance	Concordance at 1 hr	30 Joint
Group 8 (RA)	Concordance	Concordance at 3 hr	44 Joint
Group 8 (RA)	Concordance	Concordance at 1 hr	53 Joint
Group 9 (RA)	Concordance	Concordance at 1 hr	35 Joint
Group 9 (RA)	Concordance	Concordance at 3 hr	28 Joint
Group 10 (Healthy Controls)	Concordance	Concordance at 1 hr	0 Joint
Group 10 (Healthy Controls)	Concordance	Concordance at 3 hr	0 Joint
Group 11 (RA)	Concordance	Concordance at 3 hr	0 Joint
Group 11 (RA)	Concordance	Concordance at 1 hr	0 Joint

Secondary

Localization Intensity

Localization intensity is defined as the presence of Tc99m in each DAS28 joint and is output in tilmanocept uptake value (TUV) units, as computed using the following equation: 〖TUV〗=ROI/BRAIN×100 where ROI = decay-corrected avg voxel intensity of the joint ROI and BRAIN =decay-corrected avg voxel intensity of the brain RR

Time frame: Post-injection imaging at 60±15 and 180±15 min

Population: Groups 1-9 only. Groups 10 and 11 were not included.

Arm	Measure	Group	Value (MEAN)	Dispersion
Group 1 (RA)	Localization Intensity	180 ± 15 min L PIP4	133.6 TUV	Standard Deviation 22.67
Group 1 (RA)	Localization Intensity	180 ± 15 min R Knee	92.5 TUV	Standard Deviation 39.11
Group 1 (RA)	Localization Intensity	180 ± 15 min L Knee	80.5 TUV	Standard Deviation 26.7
Group 1 (RA)	Localization Intensity	60 ± 15 min L MCP5	141.9 TUV	Standard Deviation 28.51
Group 1 (RA)	Localization Intensity	180 ± 15 min R PIP5	125.7 TUV	Standard Deviation 8.97
Group 1 (RA)	Localization Intensity	60 ± 15 min R MCP4	224.4 TUV	Standard Deviation 20.27
Group 1 (RA)	Localization Intensity	60 ± 15 min R MCP2	231.7 TUV	Standard Deviation 26.52
Group 1 (RA)	Localization Intensity	60 ± 15 min R MCP 3	245.8 TUV	Standard Deviation 19.43
Group 1 (RA)	Localization Intensity	60 ± 15 min L Elbow	68.3 TUV	Standard Deviation 3.38
Group 1 (RA)	Localization Intensity	180 ± 15 min R PIP2	193.0 TUV	Standard Deviation 43.56
Group 1 (RA)	Localization Intensity	180 ± 15 min R PIP1	218.6 TUV	Standard Deviation 53.24
Group 1 (RA)	Localization Intensity	60 ± 15 min L MCP3	187.1 TUV	Standard Deviation 28.12
Group 1 (RA)	Localization Intensity	180 ± 15 min L PIP5	104.1 TUV	Standard Deviation 17.04
Group 1 (RA)	Localization Intensity	60 ± 15 min R MCP1	238.0 TUV	Standard Deviation 31.29
Group 1 (RA)	Localization Intensity	60 ± 15 min L MCP4	181.0 TUV	Standard Deviation 40.41
Group 1 (RA)	Localization Intensity	180 ± 15 min L PIP3	152.4 TUV	Standard Deviation 45.18
Group 1 (RA)	Localization Intensity	180 ± 15 min L PIP2	144.4 TUV	Standard Deviation 12.55
Group 1 (RA)	Localization Intensity	180 ± 15 min L PIP1	179.4 TUV	Standard Deviation 41.32
Group 1 (RA)	Localization Intensity	180 ± 15 min R MCP5	214.5 TUV	Standard Deviation 37.25
Group 1 (RA)	Localization Intensity	180 ± 15 min R MCP4	263.6 TUV	Standard Deviation 24.44
Group 1 (RA)	Localization Intensity	60 ± 15 min L PIP5	95.2 TUV	Standard Deviation 14.68
Group 1 (RA)	Localization Intensity	60 ± 15 min L Wrist	292.7 TUV	Standard Deviation 96.46
Group 1 (RA)	Localization Intensity	60 ± 15 min R PIP2	137.5 TUV	Standard Deviation 12.17
Group 1 (RA)	Localization Intensity	180 ± 15 min R MCP1	298.9 TUV	Standard Deviation 68.07
Group 1 (RA)	Localization Intensity	180 ± 15 min L MCP4	219.8 TUV	Standard Deviation 44.1
Group 1 (RA)	Localization Intensity	180 ± 15 min L MCP3	252.3 TUV	Standard Deviation 60.46
Group 1 (RA)	Localization Intensity	180 ± 15 min L MCP2	259.7 TUV	Standard Deviation 67.37
Group 1 (RA)	Localization Intensity	60 ± 15 min R Knee	76.2 TUV	Standard Deviation 23.25
Group 1 (RA)	Localization Intensity	180 ± 15 min L Elbow	71.8 TUV	Standard Deviation 13.49
Group 1 (RA)	Localization Intensity	180 ± 15 min L MCP1	527.8 TUV	Standard Deviation 355.31
Group 1 (RA)	Localization Intensity	180 ± 15 min R Wrist	387.6 TUV	Standard Deviation 246.92
Group 1 (RA)	Localization Intensity	180 ± 15 min R PIP4	164.6 TUV	Standard Deviation 30.74
Group 1 (RA)	Localization Intensity	180 ± 15 min L Wrist	401.8 TUV	Standard Deviation 201.69
Group 1 (RA)	Localization Intensity	180 ± 15 min R elbow	85.5 TUV	Standard Deviation 7.77
Group 1 (RA)	Localization Intensity	180 ± 15 min L MCP5	179.8 TUV	Standard Deviation 59.65
Group 1 (RA)	Localization Intensity	180 ± 15 min R Shoulder	189.1 TUV	Standard Deviation 51.36
Group 1 (RA)	Localization Intensity	180 ± 15 min R MCP2	289.9 TUV	Standard Deviation 37.14
Group 1 (RA)	Localization Intensity	180 ± 15 min L Shoulder	165.4 TUV	Standard Deviation 54.95
Group 1 (RA)	Localization Intensity	180 ± 15 min R MCP3	320.9 TUV	Standard Deviation 76.7
Group 1 (RA)	Localization Intensity	60 ± 15 min L Shoulder	138.9 TUV	Standard Deviation 27.35
Group 1 (RA)	Localization Intensity	60 ± 15 min L Knee	66.5 TUV	Standard Deviation 17.79
Group 1 (RA)	Localization Intensity	60 ± 15 min R Shoulder	156.1 TUV	Standard Deviation 19.95
Group 1 (RA)	Localization Intensity	60 ± 15 min R Wrist	387.6 TUV	Standard Deviation 246.92
Group 1 (RA)	Localization Intensity	60 ± 15 min R PIP5	107.9 TUV	Standard Deviation 13.12
Group 1 (RA)	Localization Intensity	60 ± 15 min R PIP4	133.2 TUV	Standard Deviation 19.03
Group 1 (RA)	Localization Intensity	60 ± 15 min R PIP3	156.6 TUV	Standard Deviation 6.02
Group 1 (RA)	Localization Intensity	60 ± 15 min R Elbow	87.4 TUV	Standard Deviation 4.94
Group 1 (RA)	Localization Intensity	60 ± 15 min R PIP1	165.5 TUV	Standard Deviation 6.81
Group 1 (RA)	Localization Intensity	60 ± 15 min L PIP4	109.6 TUV	Standard Deviation 8.41
Group 1 (RA)	Localization Intensity	60 ± 15 min L MCP1	192.2 TUV	Standard Deviation 5.81
Group 1 (RA)	Localization Intensity	60 ± 15 min L PIP3	125.7 TUV	Standard Deviation 7.78
Group 1 (RA)	Localization Intensity	60 ± 15 min L MCP2	175.1 TUV	Standard Deviation 23.18
Group 1 (RA)	Localization Intensity	180 ± 15 min R PIP3	182.4 TUV	Standard Deviation 14.8
Group 1 (RA)	Localization Intensity	60 ± 15 min L PIP2	120.7 TUV	Standard Deviation 14.68
Group 1 (RA)	Localization Intensity	60 ± 15 min L PIP1	130.4 TUV	Standard Deviation 5.02
Group 1 (RA)	Localization Intensity	60 ± 15 min R MCP5	182.3 TUV	Standard Deviation 4.68
Group 2 (RA)	Localization Intensity	60 ± 15 min R PIP4	200.5 TUV	Standard Deviation 83.9
Group 2 (RA)	Localization Intensity	180 ± 15 min R MCP5	373.2 TUV	Standard Deviation 122.41
Group 2 (RA)	Localization Intensity	180 ± 15 min R MCP4	380.8 TUV	Standard Deviation 38.83
Group 2 (RA)	Localization Intensity	60 ± 15 min L PIP4	172.9 TUV	Standard Deviation 20.07
Group 2 (RA)	Localization Intensity	60 ± 15 min R PIP3	189.6 TUV	Standard Deviation 18.21
Group 2 (RA)	Localization Intensity	60 ± 15 min R Wrist	420.9 TUV	Standard Deviation 59.76
Group 2 (RA)	Localization Intensity	180 ± 15 min R MCP3	428.1 TUV	Standard Deviation 5.42
Group 2 (RA)	Localization Intensity	180 ± 15 min R MCP1	344.3 TUV	Standard Deviation 25.68
Group 2 (RA)	Localization Intensity	60 ± 15 min L MCP2	394.3 TUV	Standard Deviation 152.28
Group 2 (RA)	Localization Intensity	180 ± 15 min L MCP4	414.3 TUV	Standard Deviation 76.72
Group 2 (RA)	Localization Intensity	60 ± 15 min L Wrist	415.9 TUV	Standard Deviation 55.06
Group 2 (RA)	Localization Intensity	60 ± 15 min R PIP2	184.6 TUV	Standard Deviation 33.97
Group 2 (RA)	Localization Intensity	180 ± 15 min L MCP3	456.5 TUV	Standard Deviation 90.38
Group 2 (RA)	Localization Intensity	180 ± 15 min L MCP2	378.4 TUV	Standard Deviation 212.17
Group 2 (RA)	Localization Intensity	60 ± 15 min R Elbow	88.4 TUV	—
Group 2 (RA)	Localization Intensity	180 ± 15 min L Elbow	NA TUV	—
Group 2 (RA)	Localization Intensity	180 ± 15 min R elbow	97.3 TUV	—
Group 2 (RA)	Localization Intensity	180 ± 15 min L MCP1	309.9 TUV	Standard Deviation 57.82
Group 2 (RA)	Localization Intensity	180 ± 15 min R Wrist	479.7 TUV	Standard Deviation 73.26
Group 2 (RA)	Localization Intensity	60 ± 15 min R PIP1	285.6 TUV	Standard Deviation 51.59
Group 2 (RA)	Localization Intensity	60 ± 15 min R MCP5	316.1 TUV	Standard Deviation 109.3
Group 2 (RA)	Localization Intensity	180 ± 15 min L Wrist	488.6 TUV	Standard Deviation 40.47
Group 2 (RA)	Localization Intensity	60 ± 15 min L PIP5	126.3 TUV	Standard Deviation 38.8
Group 2 (RA)	Localization Intensity	180 ± 15 min R Shoulder	240.5 TUV	Standard Deviation 118.56
Group 2 (RA)	Localization Intensity	60 ± 15 min L PIP1	239.3 TUV	Standard Deviation 91.26
Group 2 (RA)	Localization Intensity	180 ± 15 min L MCP5	413.1 TUV	Standard Deviation 81.96
Group 2 (RA)	Localization Intensity	60 ± 15 min L MCP5	323.4 TUV	Standard Deviation 77.01
Group 2 (RA)	Localization Intensity	180 ± 15 min R MCP2	495.1 TUV	Standard Deviation 256.02
Group 2 (RA)	Localization Intensity	180 ± 15 min L Shoulder	210.1 TUV	Standard Deviation 89.77
Group 2 (RA)	Localization Intensity	60 ± 15 min L MCP4	374.9 TUV	Standard Deviation 103.52
Group 2 (RA)	Localization Intensity	180 ± 15 min R Knee	126.5 TUV	Standard Deviation 47.9
Group 2 (RA)	Localization Intensity	180 ± 15 min R PIP3	224.8 TUV	Standard Deviation 21.69
Group 2 (RA)	Localization Intensity	180 ± 15 min L Knee	113.8 TUV	Standard Deviation 39.8
Group 2 (RA)	Localization Intensity	60 ± 15 min L PIP3	212.3 TUV	Standard Deviation 93.24
Group 2 (RA)	Localization Intensity	180 ± 15 min R PIP5	200.3 TUV	Standard Deviation 73.56
Group 2 (RA)	Localization Intensity	60 ± 15 min R MCP4	326.4 TUV	Standard Deviation 59.57
Group 2 (RA)	Localization Intensity	60 ± 15 min R Knee	118.8 TUV	Standard Deviation 50.05
Group 2 (RA)	Localization Intensity	60 ± 15 min R MCP2	405.4 TUV	Standard Deviation 153.35
Group 2 (RA)	Localization Intensity	180 ± 15 min R PIP2	204.7 TUV	Standard Deviation 18.16
Group 2 (RA)	Localization Intensity	60 ± 15 min R MCP 3	353.6 TUV	Standard Deviation 45.8
Group 2 (RA)	Localization Intensity	60 ± 15 min L Knee	107.4 TUV	Standard Deviation 38.98
Group 2 (RA)	Localization Intensity	60 ± 15 min L MCP1	299.2 TUV	Standard Deviation 51.36
Group 2 (RA)	Localization Intensity	180 ± 15 min R PIP1	309.0 TUV	Standard Deviation 60.52
Group 2 (RA)	Localization Intensity	60 ± 15 min R PIP5	174.7 TUV	Standard Deviation 59.35
Group 2 (RA)	Localization Intensity	60 ± 15 min L Elbow	NA TUV	—
Group 2 (RA)	Localization Intensity	180 ± 15 min L PIP5	151.0 TUV	Standard Deviation 25.51
Group 2 (RA)	Localization Intensity	60 ± 15 min L MCP3	408.7 TUV	Standard Deviation 64.48
Group 2 (RA)	Localization Intensity	60 ± 15 min R Shoulder	222.6 TUV	Standard Deviation 113.08
Group 2 (RA)	Localization Intensity	60 ± 15 min R MCP1	310.8 TUV	Standard Deviation 41.45
Group 2 (RA)	Localization Intensity	60 ± 15 min L Shoulder	193.2 TUV	Standard Deviation 85.82
Group 2 (RA)	Localization Intensity	180 ± 15 min L PIP4	185.2 TUV	Standard Deviation 10.12
Group 2 (RA)	Localization Intensity	180 ± 15 min L PIP3	257.6 TUV	Standard Deviation 126.4
Group 2 (RA)	Localization Intensity	180 ± 15 min L PIP2	165.9 TUV	Standard Deviation 44.85
Group 2 (RA)	Localization Intensity	60 ± 15 min L PIP2	158.4 TUV	Standard Deviation 55.78
Group 2 (RA)	Localization Intensity	180 ± 15 min L PIP1	270.7 TUV	Standard Deviation 98.35
Group 2 (RA)	Localization Intensity	180 ± 15 min R PIP4	376.6 TUV	Standard Deviation 103.08
Group 3 (RA)	Localization Intensity	60 ± 15 min R PIP5	88.9 TUV	Standard Deviation 54.01
Group 3 (RA)	Localization Intensity	180 ± 15 min L PIP3	157.8 TUV	Standard Deviation 72.64
Group 3 (RA)	Localization Intensity	60 ± 15 min L MCP3	259.4 TUV	Standard Deviation 118.16
Group 3 (RA)	Localization Intensity	180 ± 15 min R MCP4	271.1 TUV	Standard Deviation 101.92
Group 3 (RA)	Localization Intensity	60 ± 15 min L MCP4	204.7 TUV	Standard Deviation 78.91
Group 3 (RA)	Localization Intensity	180 ± 15 min R PIP2	174.8 TUV	Standard Deviation 67.84
Group 3 (RA)	Localization Intensity	60 ± 15 min L PIP4	106.9 TUV	Standard Deviation 43.54
Group 3 (RA)	Localization Intensity	60 ± 15 min R PIP3	124.5 TUV	Standard Deviation 74.14
Group 3 (RA)	Localization Intensity	60 ± 15 min R MCP4	189.9 TUV	Standard Deviation 102.96
Group 3 (RA)	Localization Intensity	180 ± 15 min R PIP4	175.3 TUV	Standard Deviation 78.67
Group 3 (RA)	Localization Intensity	180 ± 15 min R MCP3	286.9 TUV	Standard Deviation 118.06
Group 3 (RA)	Localization Intensity	180 ± 15 min L Knee	104.5 TUV	Standard Deviation 27.67
Group 3 (RA)	Localization Intensity	180 ± 15 min R MCP2	341.6 TUV	Standard Deviation 126.66
Group 3 (RA)	Localization Intensity	180 ± 15 min R MCP1	284.4 TUV	Standard Deviation 68.47
Group 3 (RA)	Localization Intensity	60 ± 15 min L MCP5	159.4 TUV	Standard Deviation 67.15
Group 3 (RA)	Localization Intensity	60 ± 15 min L Elbow	76.6 TUV	—
Group 3 (RA)	Localization Intensity	60 ± 15 min R PIP2	121.7 TUV	Standard Deviation 61.52
Group 3 (RA)	Localization Intensity	180 ± 15 min L MCP5	203.2 TUV	Standard Deviation 61.46
Group 3 (RA)	Localization Intensity	180 ± 15 min L MCP4	273.5 TUV	Standard Deviation 71.29
Group 3 (RA)	Localization Intensity	180 ± 15 min R PIP3	164.0 TUV	Standard Deviation 64.36
Group 3 (RA)	Localization Intensity	60 ± 15 min R PIP4	125.4 TUV	Standard Deviation 99.16
Group 3 (RA)	Localization Intensity	180 ± 15 min R PIP5	119.7 TUV	Standard Deviation 30.65
Group 3 (RA)	Localization Intensity	180 ± 15 min L PIP1	177.0 TUV	Standard Deviation 76.74
Group 3 (RA)	Localization Intensity	60 ± 15 min R Knee	99.3 TUV	Standard Deviation 36.85
Group 3 (RA)	Localization Intensity	60 ± 15 min R PIP1	141.7 TUV	Standard Deviation 71.45
Group 3 (RA)	Localization Intensity	180 ± 15 min L MCP2	404.1 TUV	Standard Deviation 168.75
Group 3 (RA)	Localization Intensity	180 ± 15 min L PIP4	150.9 TUV	Standard Deviation 48.91
Group 3 (RA)	Localization Intensity	60 ± 15 min R MCP5	153.9 TUV	Standard Deviation 85.85
Group 3 (RA)	Localization Intensity	60 ± 15 min L PIP2	105.4 TUV	Standard Deviation 49.8
Group 3 (RA)	Localization Intensity	60 ± 15 min R Elbow	NA TUV	—
Group 3 (RA)	Localization Intensity	60 ± 15 min R MCP 3	237.7 TUV	Standard Deviation 135.01
Group 3 (RA)	Localization Intensity	180 ± 15 min L Elbow	76.2 TUV	—
Group 3 (RA)	Localization Intensity	60 ± 15 min L Wrist	332.7 TUV	Standard Deviation 168.46
Group 3 (RA)	Localization Intensity	180 ± 15 min L MCP1	293.9 TUV	Standard Deviation 93.47
Group 3 (RA)	Localization Intensity	180 ± 15 min R Knee	124.0 TUV	Standard Deviation 40.28
Group 3 (RA)	Localization Intensity	180 ± 15 min R elbow	85.9 TUV	—
Group 3 (RA)	Localization Intensity	60 ± 15 min L Shoulder	188.4 TUV	Standard Deviation 92.19
Group 3 (RA)	Localization Intensity	180 ± 15 min L PIP2	151.2 TUV	Standard Deviation 38.91
Group 3 (RA)	Localization Intensity	60 ± 15 min R Wrist	351.3 TUV	Standard Deviation 139.75
Group 3 (RA)	Localization Intensity	180 ± 15 min R Wrist	482.2 TUV	Standard Deviation 169.64
Group 3 (RA)	Localization Intensity	60 ± 15 min R MCP2	285.8 TUV	Standard Deviation 106.5
Group 3 (RA)	Localization Intensity	60 ± 15 min R MCP1	230.0 TUV	Standard Deviation 73.68
Group 3 (RA)	Localization Intensity	180 ± 15 min L Wrist	434.0 TUV	Standard Deviation 183.81
Group 3 (RA)	Localization Intensity	180 ± 15 min L MCP3	327.1 TUV	Standard Deviation 97.7
Group 3 (RA)	Localization Intensity	180 ± 15 min R MCP5	218.4 TUV	Standard Deviation 67.7
Group 3 (RA)	Localization Intensity	60 ± 15 min L Knee	79.5 TUV	Standard Deviation 18.89
Group 3 (RA)	Localization Intensity	60 ± 15 min L PIP5	86.6 TUV	Standard Deviation 23.94
Group 3 (RA)	Localization Intensity	60 ± 15 min L MCP1	203.1 TUV	Standard Deviation 64.07
Group 3 (RA)	Localization Intensity	180 ± 15 min R Shoulder	230.0 TUV	Standard Deviation 81.69
Group 3 (RA)	Localization Intensity	180 ± 15 min L PIP5	124.2 TUV	Standard Deviation 27.15
Group 3 (RA)	Localization Intensity	60 ± 15 min L PIP1	127.2 TUV	Standard Deviation 48.94
Group 3 (RA)	Localization Intensity	180 ± 15 min R PIP1	202.1 TUV	Standard Deviation 67.8
Group 3 (RA)	Localization Intensity	60 ± 15 min L MCP2	318.7 TUV	Standard Deviation 148.66
Group 3 (RA)	Localization Intensity	60 ± 15 min L PIP3	117.0 TUV	Standard Deviation 58.62
Group 3 (RA)	Localization Intensity	60 ± 15 min R Shoulder	181.2 TUV	Standard Deviation 73.69
Group 3 (RA)	Localization Intensity	180 ± 15 min L Shoulder	232.2 TUV	Standard Deviation 116.41
Group 4 (RA)	Localization Intensity	180 ± 15 min R PIP4	213.4 TUV	Standard Deviation 147.22
Group 4 (RA)	Localization Intensity	60 ± 15 min L Shoulder	177.9 TUV	Standard Deviation 64.22
Group 4 (RA)	Localization Intensity	60 ± 15 min L Wrist	416.1 TUV	Standard Deviation 202
Group 4 (RA)	Localization Intensity	60 ± 15 min L MCP1	230.2 TUV	Standard Deviation 97.52
Group 4 (RA)	Localization Intensity	60 ± 15 min L MCP3	228.7 TUV	Standard Deviation 123.51
Group 4 (RA)	Localization Intensity	60 ± 15 min L MCP5	207.1 TUV	Standard Deviation 87.17
Group 4 (RA)	Localization Intensity	60 ± 15 min R MCP1	261.1 TUV	Standard Deviation 155.97
Group 4 (RA)	Localization Intensity	60 ± 15 min R MCP4	231.4 TUV	Standard Deviation 147.1
Group 4 (RA)	Localization Intensity	60 ± 15 min L PIP1	196.6 TUV	Standard Deviation 98.77
Group 4 (RA)	Localization Intensity	60 ± 15 min L PIP5	138.5 TUV	Standard Deviation 89.37
Group 4 (RA)	Localization Intensity	60 ± 15 min R PIP4	161.3 TUV	Standard Deviation 93.41
Group 4 (RA)	Localization Intensity	180 ± 15 min L Elbow	102.4 TUV	Standard Deviation 49.11
Group 4 (RA)	Localization Intensity	180 ± 15 min R elbow	109.3 TUV	Standard Deviation 44.46
Group 4 (RA)	Localization Intensity	180 ± 15 min L MCP3	317.3 TUV	Standard Deviation 184.41
Group 4 (RA)	Localization Intensity	180 ± 15 min R PIP3	239.6 TUV	Standard Deviation 135.4
Group 4 (RA)	Localization Intensity	60 ± 15 min R Shoulder	179.5 TUV	Standard Deviation 65.66
Group 4 (RA)	Localization Intensity	60 ± 15 min L Elbow	NA TUV	—
Group 4 (RA)	Localization Intensity	60 ± 15 min R Elbow	94.7 TUV	Standard Deviation 19.29
Group 4 (RA)	Localization Intensity	60 ± 15 min R Wrist	458.5 TUV	Standard Deviation 282.25
Group 4 (RA)	Localization Intensity	60 ± 15 min L MCP2	243.8 TUV	Standard Deviation 101.78
Group 4 (RA)	Localization Intensity	60 ± 15 min L MCP4	225.3 TUV	Standard Deviation 93.15
Group 4 (RA)	Localization Intensity	60 ± 15 min R MCP2	295.1 TUV	Standard Deviation 227.83
Group 4 (RA)	Localization Intensity	60 ± 15 min R MCP 3	296.9 TUV	Standard Deviation 156.42
Group 4 (RA)	Localization Intensity	180 ± 15 min R PIP5	181.4 TUV	Standard Deviation 90.31
Group 4 (RA)	Localization Intensity	180 ± 15 min L Knee	126.1 TUV	Standard Deviation 43.18
Group 4 (RA)	Localization Intensity	180 ± 15 min R Knee	122.1 TUV	Standard Deviation 40.79
Group 4 (RA)	Localization Intensity	60 ± 15 min R MCP5	208.0 TUV	Standard Deviation 140.89
Group 4 (RA)	Localization Intensity	60 ± 15 min L PIP2	153.3 TUV	Standard Deviation 72.08
Group 4 (RA)	Localization Intensity	60 ± 15 min L PIP3	170.1 TUV	Standard Deviation 105.66
Group 4 (RA)	Localization Intensity	60 ± 15 min L PIP4	151.8 TUV	Standard Deviation 56.55
Group 4 (RA)	Localization Intensity	60 ± 15 min R PIP1	171.3 TUV	Standard Deviation 71.34
Group 4 (RA)	Localization Intensity	60 ± 15 min R PIP2	194.8 TUV	Standard Deviation 97.92
Group 4 (RA)	Localization Intensity	60 ± 15 min R PIP3	215.0 TUV	Standard Deviation 127.88
Group 4 (RA)	Localization Intensity	60 ± 15 min R PIP5	144.3 TUV	Standard Deviation 66
Group 4 (RA)	Localization Intensity	180 ± 15 min L Shoulder	211.0 TUV	Standard Deviation 81.71
Group 4 (RA)	Localization Intensity	60 ± 15 min L Knee	101.4 TUV	Standard Deviation 23.4
Group 4 (RA)	Localization Intensity	60 ± 15 min R Knee	98.3 TUV	Standard Deviation 22.13
Group 4 (RA)	Localization Intensity	180 ± 15 min R Shoulder	209.3 TUV	Standard Deviation 86.04
Group 4 (RA)	Localization Intensity	180 ± 15 min L Wrist	514.7 TUV	Standard Deviation 275.68
Group 4 (RA)	Localization Intensity	180 ± 15 min R Wrist	582.1 TUV	Standard Deviation 411.89
Group 4 (RA)	Localization Intensity	180 ± 15 min L MCP1	321.2 TUV	Standard Deviation 169.11
Group 4 (RA)	Localization Intensity	180 ± 15 min L MCP2	316.1 TUV	Standard Deviation 114.5
Group 4 (RA)	Localization Intensity	180 ± 15 min L MCP4	278.8 TUV	Standard Deviation 139.18
Group 4 (RA)	Localization Intensity	180 ± 15 min L MCP5	264.4 TUV	Standard Deviation 165.09
Group 4 (RA)	Localization Intensity	180 ± 15 min R MCP1	351.1 TUV	Standard Deviation 222.79
Group 4 (RA)	Localization Intensity	180 ± 15 min R MCP2	405.0 TUV	Standard Deviation 343.2
Group 4 (RA)	Localization Intensity	180 ± 15 min R MCP3	404.0 TUV	Standard Deviation 242.78
Group 4 (RA)	Localization Intensity	180 ± 15 min R MCP4	320.0 TUV	Standard Deviation 202.62
Group 4 (RA)	Localization Intensity	180 ± 15 min R MCP5	276.1 TUV	Standard Deviation 168.15
Group 4 (RA)	Localization Intensity	180 ± 15 min L PIP1	220.4 TUV	Standard Deviation 125.71
Group 4 (RA)	Localization Intensity	180 ± 15 min L PIP2	209.8 TUV	Standard Deviation 116.11
Group 4 (RA)	Localization Intensity	180 ± 15 min L PIP3	215.3 TUV	Standard Deviation 120.83
Group 4 (RA)	Localization Intensity	180 ± 15 min L PIP4	195.7 TUV	Standard Deviation 120.38
Group 4 (RA)	Localization Intensity	180 ± 15 min L PIP5	191.1 TUV	Standard Deviation 149.39
Group 4 (RA)	Localization Intensity	180 ± 15 min R PIP1	221.3 TUV	Standard Deviation 133.9
Group 4 (RA)	Localization Intensity	180 ± 15 min R PIP2	256.4 TUV	Standard Deviation 140.51
Group 5 (RA)	Localization Intensity	60 ± 15 min L MCP5	206.5 TUV	Standard Deviation 101.51
Group 5 (RA)	Localization Intensity	180 ± 15 min L MCP3	302.4 TUV	Standard Deviation 146.85
Group 5 (RA)	Localization Intensity	60 ± 15 min L Elbow	NA TUV	—
Group 5 (RA)	Localization Intensity	180 ± 15 min R elbow	71.2 TUV	—
Group 5 (RA)	Localization Intensity	180 ± 15 min R Shoulder	177.6 TUV	Standard Deviation 54.82
Group 5 (RA)	Localization Intensity	180 ± 15 min R PIP5	148.5 TUV	Standard Deviation 64.16
Group 5 (RA)	Localization Intensity	60 ± 15 min R PIP3	140.7 TUV	Standard Deviation 30.08
Group 5 (RA)	Localization Intensity	180 ± 15 min L Shoulder	160.8 TUV	Standard Deviation 55.63
Group 5 (RA)	Localization Intensity	60 ± 15 min R Knee	78.7 TUV	Standard Deviation 14.07
Group 5 (RA)	Localization Intensity	180 ± 15 min R PIP3	184.9 TUV	Standard Deviation 76.62
Group 5 (RA)	Localization Intensity	180 ± 15 min L PIP4	167.2 TUV	Standard Deviation 96.27
Group 5 (RA)	Localization Intensity	60 ± 15 min L Knee	79.6 TUV	Standard Deviation 15.84
Group 5 (RA)	Localization Intensity	60 ± 15 min L Shoulder	135.0 TUV	Standard Deviation 31.9
Group 5 (RA)	Localization Intensity	60 ± 15 min R PIP5	104.0 TUV	Standard Deviation 33.68
Group 5 (RA)	Localization Intensity	60 ± 15 min R Shoulder	145.7 TUV	Standard Deviation 26.65
Group 5 (RA)	Localization Intensity	60 ± 15 min R MCP5	162.2 TUV	Standard Deviation 53.15
Group 5 (RA)	Localization Intensity	60 ± 15 min R MCP1	254.9 TUV	Standard Deviation 78.65
Group 5 (RA)	Localization Intensity	180 ± 15 min R Knee	105.3 TUV	Standard Deviation 23.75
Group 5 (RA)	Localization Intensity	60 ± 15 min R MCP 3	229.1 TUV	Standard Deviation 72.37
Group 5 (RA)	Localization Intensity	60 ± 15 min L MCP2	177.0 TUV	Standard Deviation 80.29
Group 5 (RA)	Localization Intensity	180 ± 15 min L PIP3	160.7 TUV	Standard Deviation 81.29
Group 5 (RA)	Localization Intensity	60 ± 15 min L MCP4	214.8 TUV	Standard Deviation 93.5
Group 5 (RA)	Localization Intensity	180 ± 15 min L PIP2	189.5 TUV	Standard Deviation 106.68
Group 5 (RA)	Localization Intensity	60 ± 15 min L PIP2	129.8 TUV	Standard Deviation 55.88
Group 5 (RA)	Localization Intensity	180 ± 15 min L PIP1	224.0 TUV	Standard Deviation 146.46
Group 5 (RA)	Localization Intensity	60 ± 15 min L PIP1	148.4 TUV	Standard Deviation 53.25
Group 5 (RA)	Localization Intensity	60 ± 15 min L MCP1	222.9 TUV	Standard Deviation 81.58
Group 5 (RA)	Localization Intensity	60 ± 15 min R Wrist	271.9 TUV	Standard Deviation 88.55
Group 5 (RA)	Localization Intensity	180 ± 15 min R PIP4	170.3 TUV	Standard Deviation 97.9
Group 5 (RA)	Localization Intensity	180 ± 15 min R MCP5	262.1 TUV	Standard Deviation 140.52
Group 5 (RA)	Localization Intensity	60 ± 15 min L PIP3	129.8 TUV	Standard Deviation 65.39
Group 5 (RA)	Localization Intensity	180 ± 15 min L PIP5	143.7 TUV	Standard Deviation 98.53
Group 5 (RA)	Localization Intensity	180 ± 15 min R MCP4	284.2 TUV	Standard Deviation 137.2
Group 5 (RA)	Localization Intensity	180 ± 15 min R MCP3	300.1 TUV	Standard Deviation 171.48
Group 5 (RA)	Localization Intensity	180 ± 15 min R MCP2	271.4 TUV	Standard Deviation 146.89
Group 5 (RA)	Localization Intensity	180 ± 15 min R MCP1	288.4 TUV	Standard Deviation 127.85
Group 5 (RA)	Localization Intensity	180 ± 15 min L MCP5	251.9 TUV	Standard Deviation 128.7
Group 5 (RA)	Localization Intensity	60 ± 15 min L PIP4	126.3 TUV	Standard Deviation 58.4
Group 5 (RA)	Localization Intensity	60 ± 15 min R MCP2	188.6 TUV	Standard Deviation 58.65
Group 5 (RA)	Localization Intensity	180 ± 15 min L MCP4	261.5 TUV	Standard Deviation 128.77
Group 5 (RA)	Localization Intensity	60 ± 15 min R PIP4	143.0 TUV	Standard Deviation 53.77
Group 5 (RA)	Localization Intensity	180 ± 15 min L MCP2	252.7 TUV	Standard Deviation 139.89
Group 5 (RA)	Localization Intensity	60 ± 15 min L Wrist	246.3 TUV	Standard Deviation 109.9
Group 5 (RA)	Localization Intensity	60 ± 15 min L PIP5	108.9 TUV	Standard Deviation 66.64
Group 5 (RA)	Localization Intensity	60 ± 15 min R MCP4	223.3 TUV	Standard Deviation 78.82
Group 5 (RA)	Localization Intensity	180 ± 15 min L MCP1	300.3 TUV	Standard Deviation 136.28
Group 5 (RA)	Localization Intensity	180 ± 15 min R PIP2	187.3 TUV	Standard Deviation 75.12
Group 5 (RA)	Localization Intensity	180 ± 15 min L Knee	98.6 TUV	Standard Deviation 25.98
Group 5 (RA)	Localization Intensity	60 ± 15 min R Elbow	76.5 TUV	—
Group 5 (RA)	Localization Intensity	180 ± 15 min L Elbow	57.7 TUV	—
Group 5 (RA)	Localization Intensity	180 ± 15 min R Wrist	404.5 TUV	Standard Deviation 177.65
Group 5 (RA)	Localization Intensity	60 ± 15 min R PIP1	152.8 TUV	Standard Deviation 48.86
Group 5 (RA)	Localization Intensity	180 ± 15 min L Wrist	299.7 TUV	Standard Deviation 126.01
Group 5 (RA)	Localization Intensity	60 ± 15 min L MCP3	206.7 TUV	Standard Deviation 87.69
Group 5 (RA)	Localization Intensity	180 ± 15 min R PIP1	222.0 TUV	Standard Deviation 117.48
Group 5 (RA)	Localization Intensity	60 ± 15 min R PIP2	139.7 TUV	Standard Deviation 56.9
Group 6 (RA)	Localization Intensity	60 ± 15 min L MCP4	185.5 TUV	Standard Deviation 50.83
Group 6 (RA)	Localization Intensity	180 ± 15 min R Knee	76.5 TUV	Standard Deviation 11.68
Group 6 (RA)	Localization Intensity	60 ± 15 min R MCP4	242.7 TUV	Standard Deviation 143.34
Group 6 (RA)	Localization Intensity	60 ± 15 min L MCP3	187.9 TUV	Standard Deviation 44.78
Group 6 (RA)	Localization Intensity	60 ± 15 min L MCP2	167.6 TUV	Standard Deviation 43.83
Group 6 (RA)	Localization Intensity	60 ± 15 min L MCP1	186.0 TUV	Standard Deviation 18.29
Group 6 (RA)	Localization Intensity	60 ± 15 min L MCP5	166.2 TUV	Standard Deviation 34.36
Group 6 (RA)	Localization Intensity	60 ± 15 min L PIP3	120.2 TUV	Standard Deviation 12.47
Group 6 (RA)	Localization Intensity	60 ± 15 min L PIP4	117.5 TUV	Standard Deviation 24.73
Group 6 (RA)	Localization Intensity	60 ± 15 min L PIP5	96.4 TUV	Standard Deviation 13.92
Group 6 (RA)	Localization Intensity	60 ± 15 min R Elbow	NA TUV	—
Group 6 (RA)	Localization Intensity	60 ± 15 min L Elbow	NA TUV	—
Group 6 (RA)	Localization Intensity	60 ± 15 min R PIP2	133.3 TUV	Standard Deviation 49.95
Group 6 (RA)	Localization Intensity	180 ± 15 min R PIP1	194.1 TUV	Standard Deviation 32.36
Group 6 (RA)	Localization Intensity	60 ± 15 min R Shoulder	140.8 TUV	Standard Deviation 12.82
Group 6 (RA)	Localization Intensity	60 ± 15 min R PIP5	104.3 TUV	Standard Deviation 29.19
Group 6 (RA)	Localization Intensity	60 ± 15 min L Shoulder	146.1 TUV	Standard Deviation 35.54
Group 6 (RA)	Localization Intensity	60 ± 15 min R Knee	67.1 TUV	Standard Deviation 8.62
Group 6 (RA)	Localization Intensity	180 ± 15 min L Shoulder	163.0 TUV	Standard Deviation 37.4
Group 6 (RA)	Localization Intensity	180 ± 15 min R Shoulder	148.9 TUV	Standard Deviation 12.6
Group 6 (RA)	Localization Intensity	180 ± 15 min L Elbow	NA TUV	—
Group 6 (RA)	Localization Intensity	180 ± 15 min R elbow	NA TUV	—
Group 6 (RA)	Localization Intensity	180 ± 15 min L Wrist	404.1 TUV	Standard Deviation 126.88
Group 6 (RA)	Localization Intensity	180 ± 15 min R Wrist	465.1 TUV	Standard Deviation 269.97
Group 6 (RA)	Localization Intensity	180 ± 15 min L MCP1	216.6 TUV	Standard Deviation 17.24
Group 6 (RA)	Localization Intensity	180 ± 15 min R PIP2	164.9 TUV	Standard Deviation 57.27
Group 6 (RA)	Localization Intensity	180 ± 15 min L MCP2	225.7 TUV	Standard Deviation 30.86
Group 6 (RA)	Localization Intensity	60 ± 15 min L Knee	78.5 TUV	Standard Deviation 32.65
Group 6 (RA)	Localization Intensity	60 ± 15 min R PIP4	143.6 TUV	Standard Deviation 57.59
Group 6 (RA)	Localization Intensity	180 ± 15 min L MCP3	220.4 TUV	Standard Deviation 63.17
Group 6 (RA)	Localization Intensity	60 ± 15 min R PIP3	168.1 TUV	Standard Deviation 95.49
Group 6 (RA)	Localization Intensity	180 ± 15 min L MCP4	195.4 TUV	Standard Deviation 39.1
Group 6 (RA)	Localization Intensity	180 ± 15 min L MCP5	184.4 TUV	Standard Deviation 44.55
Group 6 (RA)	Localization Intensity	180 ± 15 min R MCP1	258.6 TUV	Standard Deviation 71.85
Group 6 (RA)	Localization Intensity	180 ± 15 min R MCP2	300.3 TUV	Standard Deviation 147.97
Group 6 (RA)	Localization Intensity	60 ± 15 min R PIP1	148.7 TUV	Standard Deviation 6.24
Group 6 (RA)	Localization Intensity	60 ± 15 min R Wrist	432.4 TUV	Standard Deviation 268.22
Group 6 (RA)	Localization Intensity	180 ± 15 min R MCP3	298.2 TUV	Standard Deviation 138.42
Group 6 (RA)	Localization Intensity	60 ± 15 min L PIP2	126.0 TUV	Standard Deviation 17.08
Group 6 (RA)	Localization Intensity	180 ± 15 min R MCP4	271.2 TUV	Standard Deviation 73.89
Group 6 (RA)	Localization Intensity	60 ± 15 min L PIP1	134.8 TUV	Standard Deviation 21
Group 6 (RA)	Localization Intensity	180 ± 15 min R PIP3	198.0 TUV	Standard Deviation 85.74
Group 6 (RA)	Localization Intensity	180 ± 15 min R MCP5	187.3 TUV	Standard Deviation 34.76
Group 6 (RA)	Localization Intensity	180 ± 15 min L PIP1	156.1 TUV	Standard Deviation 8.23
Group 6 (RA)	Localization Intensity	60 ± 15 min R MCP5	192.0 TUV	Standard Deviation 69.35
Group 6 (RA)	Localization Intensity	180 ± 15 min L PIP2	142.4 TUV	Standard Deviation 18.6
Group 6 (RA)	Localization Intensity	180 ± 15 min L PIP3	155.2 TUV	Standard Deviation 54.09
Group 6 (RA)	Localization Intensity	60 ± 15 min R MCP 3	234.8 TUV	Standard Deviation 122.53
Group 6 (RA)	Localization Intensity	60 ± 15 min L Wrist	358.4 TUV	Standard Deviation 136.55
Group 6 (RA)	Localization Intensity	180 ± 15 min L PIP4	157.8 TUV	Standard Deviation 28.39
Group 6 (RA)	Localization Intensity	60 ± 15 min R MCP2	272.7 TUV	Standard Deviation 183.37
Group 6 (RA)	Localization Intensity	180 ± 15 min R PIP4	182.8 TUV	Standard Deviation 47.32
Group 6 (RA)	Localization Intensity	60 ± 15 min R MCP1	226.3 TUV	Standard Deviation 57.31
Group 6 (RA)	Localization Intensity	180 ± 15 min L PIP5	109.1 TUV	Standard Deviation 16.35
Group 6 (RA)	Localization Intensity	180 ± 15 min R PIP5	117.3 TUV	Standard Deviation 44.55
Group 6 (RA)	Localization Intensity	180 ± 15 min L Knee	87.5 TUV	Standard Deviation 37.21
Group 7 (RA)	Localization Intensity	60 ± 15 min R PIP2	215.1 TUV	Standard Deviation 35.17
Group 7 (RA)	Localization Intensity	60 ± 15 min R MCP4	259.0 TUV	Standard Deviation 62.48
Group 7 (RA)	Localization Intensity	180 ± 15 min R MCP2	294.3 TUV	Standard Deviation 40.2
Group 7 (RA)	Localization Intensity	180 ± 15 min L PIP2	227.5 TUV	Standard Deviation 50.02
Group 7 (RA)	Localization Intensity	180 ± 15 min R PIP5	147.5 TUV	Standard Deviation 47.18
Group 7 (RA)	Localization Intensity	180 ± 15 min R Shoulder	221.6 TUV	Standard Deviation 59.4
Group 7 (RA)	Localization Intensity	180 ± 15 min R MCP1	346.9 TUV	Standard Deviation 33.49
Group 7 (RA)	Localization Intensity	60 ± 15 min R Knee	91.1 TUV	Standard Deviation 14.44
Group 7 (RA)	Localization Intensity	60 ± 15 min R PIP1	208.5 TUV	Standard Deviation 39.27
Group 7 (RA)	Localization Intensity	60 ± 15 min R Wrist	465.5 TUV	Standard Deviation 254.62
Group 7 (RA)	Localization Intensity	60 ± 15 min R MCP5	219.6 TUV	Standard Deviation 86.83
Group 7 (RA)	Localization Intensity	180 ± 15 min L PIP1	206.3 TUV	Standard Deviation 25.63
Group 7 (RA)	Localization Intensity	180 ± 15 min R Knee	107.5 TUV	Standard Deviation 37.05
Group 7 (RA)	Localization Intensity	180 ± 15 min R PIP3	255.0 TUV	Standard Deviation 65.78
Group 7 (RA)	Localization Intensity	180 ± 15 min R MCP5	270.6 TUV	Standard Deviation 58.95
Group 7 (RA)	Localization Intensity	180 ± 15 min R Wrist	565.6 TUV	Standard Deviation 283.4
Group 7 (RA)	Localization Intensity	180 ± 15 min R PIP4	243.5 TUV	Standard Deviation 36.6
Group 7 (RA)	Localization Intensity	180 ± 15 min R MCP3	330.5 TUV	Standard Deviation 97.94
Group 7 (RA)	Localization Intensity	180 ± 15 min L PIP4	249.7 TUV	Standard Deviation 77.85
Group 7 (RA)	Localization Intensity	180 ± 15 min L Knee	101.2 TUV	Standard Deviation 32.64
Group 7 (RA)	Localization Intensity	60 ± 15 min L MCP5	236.1 TUV	Standard Deviation 42.07
Group 7 (RA)	Localization Intensity	60 ± 15 min L PIP2	177.9 TUV	Standard Deviation 18.887
Group 7 (RA)	Localization Intensity	60 ± 15 min L PIP1	201.2 TUV	Standard Deviation 113.75
Group 7 (RA)	Localization Intensity	60 ± 15 min L Wrist	387.4 TUV	Standard Deviation 157.13
Group 7 (RA)	Localization Intensity	60 ± 15 min L PIP3	201.1 TUV	Standard Deviation 48.49
Group 7 (RA)	Localization Intensity	60 ± 15 min R Shoulder	180.1 TUV	Standard Deviation 18.23
Group 7 (RA)	Localization Intensity	180 ± 15 min R MCP4	255.3 TUV	Standard Deviation 56.27
Group 7 (RA)	Localization Intensity	60 ± 15 min L PIP5	149.5 TUV	Standard Deviation 54.15
Group 7 (RA)	Localization Intensity	60 ± 15 min L Shoulder	177.6 TUV	Standard Deviation 19.37
Group 7 (RA)	Localization Intensity	60 ± 15 min R PIP5	186.8 TUV	Standard Deviation 36.75
Group 7 (RA)	Localization Intensity	60 ± 15 min L MCP3	286.5 TUV	Standard Deviation 26.59
Group 7 (RA)	Localization Intensity	60 ± 15 min L Knee	86.8 TUV	Standard Deviation 14.06
Group 7 (RA)	Localization Intensity	180 ± 15 min L PIP5	219.4 TUV	Standard Deviation 95.36
Group 7 (RA)	Localization Intensity	180 ± 15 min L Shoulder	218.0 TUV	Standard Deviation 67.76
Group 7 (RA)	Localization Intensity	60 ± 15 min L MCP4	253.1 TUV	Standard Deviation 61.97
Group 7 (RA)	Localization Intensity	180 ± 15 min L MCP2	300.6 TUV	Standard Deviation 157.04
Group 7 (RA)	Localization Intensity	60 ± 15 min R MCP2	286.7 TUV	Standard Deviation 46.46
Group 7 (RA)	Localization Intensity	180 ± 15 min R PIP1	303.2 TUV	Standard Deviation 62.42
Group 7 (RA)	Localization Intensity	60 ± 15 min L MCP2	333.5 TUV	Standard Deviation 68.95
Group 7 (RA)	Localization Intensity	180 ± 15 min L Wrist	457.9 TUV	Standard Deviation 157.64
Group 7 (RA)	Localization Intensity	180 ± 15 min R elbow	102.1 TUV	Standard Deviation 28.42
Group 7 (RA)	Localization Intensity	180 ± 15 min L MCP3	393.1 TUV	Standard Deviation 57.8
Group 7 (RA)	Localization Intensity	60 ± 15 min L Elbow	104.7 TUV	Standard Deviation 22.16
Group 7 (RA)	Localization Intensity	60 ± 15 min R PIP3	191.8 TUV	Standard Deviation 43.07
Group 7 (RA)	Localization Intensity	180 ± 15 min L PIP3	224.2 TUV	Standard Deviation 5.85
Group 7 (RA)	Localization Intensity	180 ± 15 min R PIP2	211.9 TUV	Standard Deviation 56.41
Group 7 (RA)	Localization Intensity	60 ± 15 min L PIP4	163.8 TUV	Standard Deviation 53.06
Group 7 (RA)	Localization Intensity	180 ± 15 min L Elbow	94.6 TUV	Standard Deviation 13.84
Group 7 (RA)	Localization Intensity	180 ± 15 min L MCP4	361.9 TUV	Standard Deviation 60.33
Group 7 (RA)	Localization Intensity	180 ± 15 min L MCP1	259.7 TUV	Standard Deviation 56.52
Group 7 (RA)	Localization Intensity	60 ± 15 min R PIP4	160.7 TUV	Standard Deviation 50.81
Group 7 (RA)	Localization Intensity	60 ± 15 min L MCP1	241.4 TUV	Standard Deviation 41.31
Group 7 (RA)	Localization Intensity	60 ± 15 min R MCP1	261.6 TUV	Standard Deviation 27.81
Group 7 (RA)	Localization Intensity	180 ± 15 min L MCP5	276.4 TUV	Standard Deviation 62.35
Group 7 (RA)	Localization Intensity	60 ± 15 min R Elbow	110.3 TUV	Standard Deviation 14.34
Group 7 (RA)	Localization Intensity	60 ± 15 min R MCP 3	267.8 TUV	Standard Deviation 44.47
Group 8 (RA)	Localization Intensity	60 ± 15 min L PIP4	215.6 TUV	Standard Deviation 152.95
Group 8 (RA)	Localization Intensity	180 ± 15 min R elbow	94.3 TUV	Standard Deviation 4.39
Group 8 (RA)	Localization Intensity	180 ± 15 min L MCP3	364.2 TUV	Standard Deviation 210.61
Group 8 (RA)	Localization Intensity	60 ± 15 min R Wrist	492.0 TUV	Standard Deviation 351.8
Group 8 (RA)	Localization Intensity	60 ± 15 min L Elbow	82.3 TUV	Standard Deviation 15.04
Group 8 (RA)	Localization Intensity	180 ± 15 min L Wrist	566.6 TUV	Standard Deviation 374.43
Group 8 (RA)	Localization Intensity	180 ± 15 min L MCP1	297.4 TUV	Standard Deviation 107.98
Group 8 (RA)	Localization Intensity	60 ± 15 min R Elbow	101.1 TUV	Standard Deviation 16.15
Group 8 (RA)	Localization Intensity	60 ± 15 min R MCP2	269.6 TUV	Standard Deviation 167.41
Group 8 (RA)	Localization Intensity	180 ± 15 min R Wrist	534.7 TUV	Standard Deviation 314.36
Group 8 (RA)	Localization Intensity	60 ± 15 min L PIP5	215.6 TUV	Standard Deviation 183.5
Group 8 (RA)	Localization Intensity	60 ± 15 min L Knee	176.7 TUV	Standard Deviation 170.34
Group 8 (RA)	Localization Intensity	60 ± 15 min L Wrist	472.9 TUV	Standard Deviation 386.02
Group 8 (RA)	Localization Intensity	180 ± 15 min L MCP2	364.3 TUV	Standard Deviation 184.71
Group 8 (RA)	Localization Intensity	180 ± 15 min R Knee	191.4 TUV	Standard Deviation 180.37
Group 8 (RA)	Localization Intensity	60 ± 15 min R MCP 3	323.9 TUV	Standard Deviation 288.11
Group 8 (RA)	Localization Intensity	180 ± 15 min L Elbow	101.2 TUV	Standard Deviation 25.92
Group 8 (RA)	Localization Intensity	60 ± 15 min R MCP1	354.4 TUV	Standard Deviation 162.04
Group 8 (RA)	Localization Intensity	60 ± 15 min R PIP2	198.1 TUV	Standard Deviation 144.14
Group 8 (RA)	Localization Intensity	180 ± 15 min R PIP2	200.5 TUV	Standard Deviation 47.74
Group 8 (RA)	Localization Intensity	180 ± 15 min L MCP5	298.0 TUV	Standard Deviation 104.1
Group 8 (RA)	Localization Intensity	60 ± 15 min R PIP1	244.8 TUV	Standard Deviation 154.04
Group 8 (RA)	Localization Intensity	180 ± 15 min R PIP4	292.8 TUV	Standard Deviation 174.85
Group 8 (RA)	Localization Intensity	180 ± 15 min R MCP1	356.0 TUV	Standard Deviation 64.44
Group 8 (RA)	Localization Intensity	60 ± 15 min L PIP3	204.0 TUV	Standard Deviation 160.22
Group 8 (RA)	Localization Intensity	180 ± 15 min R MCP3	385.2 TUV	Standard Deviation 256.76
Group 8 (RA)	Localization Intensity	60 ± 15 min L MCP5	220.3 TUV	Standard Deviation 152.82
Group 8 (RA)	Localization Intensity	180 ± 15 min R MCP4	361.8 TUV	Standard Deviation 223.67
Group 8 (RA)	Localization Intensity	60 ± 15 min L PIP1	166.8 TUV	Standard Deviation 100.57
Group 8 (RA)	Localization Intensity	60 ± 15 min L MCP2	323.6 TUV	Standard Deviation 263.03
Group 8 (RA)	Localization Intensity	180 ± 15 min L PIP5	183.6 TUV	Standard Deviation 85.21
Group 8 (RA)	Localization Intensity	180 ± 15 min R MCP5	332.5 TUV	Standard Deviation 162.83
Group 8 (RA)	Localization Intensity	60 ± 15 min R MCP5	222.1 TUV	Standard Deviation 117.16
Group 8 (RA)	Localization Intensity	60 ± 15 min L PIP2	129.9 TUV	Standard Deviation 41.93
Group 8 (RA)	Localization Intensity	180 ± 15 min L Knee	193.7 TUV	Standard Deviation 177.1
Group 8 (RA)	Localization Intensity	180 ± 15 min L PIP1	275.1 TUV	Standard Deviation 74.03
Group 8 (RA)	Localization Intensity	180 ± 15 min R PIP3	263.1 TUV	Standard Deviation 120.11
Group 8 (RA)	Localization Intensity	180 ± 15 min R PIP5	233.4 TUV	Standard Deviation 102.14
Group 8 (RA)	Localization Intensity	180 ± 15 min L PIP2	285.4 TUV	Standard Deviation 229.72
Group 8 (RA)	Localization Intensity	60 ± 15 min R MCP4	265.8 TUV	Standard Deviation 137.12
Group 8 (RA)	Localization Intensity	180 ± 15 min L PIP3	285.6 TUV	Standard Deviation 241.39
Group 8 (RA)	Localization Intensity	60 ± 15 min L MCP4	240.9 TUV	Standard Deviation 221.84
Group 8 (RA)	Localization Intensity	60 ± 15 min L Shoulder	269.3 TUV	Standard Deviation 238.6
Group 8 (RA)	Localization Intensity	60 ± 15 min R PIP5	170.9 TUV	Standard Deviation 91.39
Group 8 (RA)	Localization Intensity	180 ± 15 min R PIP1	261.8 TUV	Standard Deviation 138.92
Group 8 (RA)	Localization Intensity	60 ± 15 min R PIP4	221.6 TUV	Standard Deviation 161.97
Group 8 (RA)	Localization Intensity	60 ± 15 min L MCP1	250.7 TUV	Standard Deviation 95.14
Group 8 (RA)	Localization Intensity	180 ± 15 min L PIP4	246.4 TUV	Standard Deviation 191.83
Group 8 (RA)	Localization Intensity	60 ± 15 min R Knee	165.4 TUV	Standard Deviation 174.57
Group 8 (RA)	Localization Intensity	180 ± 15 min R MCP2	397.0 TUV	Standard Deviation 170.33
Group 8 (RA)	Localization Intensity	60 ± 15 min R PIP3	224.3 TUV	Standard Deviation 141.68
Group 8 (RA)	Localization Intensity	180 ± 15 min L Shoulder	301.4 TUV	Standard Deviation 254.58
Group 8 (RA)	Localization Intensity	180 ± 15 min L MCP4	315.2 TUV	Standard Deviation 195.4
Group 8 (RA)	Localization Intensity	60 ± 15 min R Shoulder	293.8 TUV	Standard Deviation 255.64
Group 8 (RA)	Localization Intensity	180 ± 15 min R Shoulder	321.0 TUV	Standard Deviation 237.86
Group 8 (RA)	Localization Intensity	60 ± 15 min L MCP3	324.0 TUV	Standard Deviation 258.57
Group 9 (RA)	Localization Intensity	180 ± 15 min R elbow	90.9 TUV	Standard Deviation 5.49
Group 9 (RA)	Localization Intensity	60 ± 15 min R PIP1	239.4 TUV	Standard Deviation 74.89
Group 9 (RA)	Localization Intensity	180 ± 15 min L MCP5	228.8 TUV	Standard Deviation 43.52
Group 9 (RA)	Localization Intensity	180 ± 15 min R PIP3	229.3 TUV	Standard Deviation 44.24
Group 9 (RA)	Localization Intensity	60 ± 15 min L MCP1	326.9 TUV	Standard Deviation 123.01
Group 9 (RA)	Localization Intensity	180 ± 15 min R PIP5	197.7 TUV	Standard Deviation 50.77
Group 9 (RA)	Localization Intensity	60 ± 15 min R MCP 3	336.0 TUV	Standard Deviation 158.66
Group 9 (RA)	Localization Intensity	60 ± 15 min R Shoulder	184.8 TUV	Standard Deviation 17.51
Group 9 (RA)	Localization Intensity	180 ± 15 min L PIP3	204.4 TUV	Standard Deviation 84.03
Group 9 (RA)	Localization Intensity	60 ± 15 min L MCP4	211.7 TUV	Standard Deviation 75.61
Group 9 (RA)	Localization Intensity	60 ± 15 min L PIP1	243.9 TUV	Standard Deviation 14.08
Group 9 (RA)	Localization Intensity	60 ± 15 min R MCP1	349.4 TUV	Standard Deviation 213.53
Group 9 (RA)	Localization Intensity	60 ± 15 min L MCP5	220.9 TUV	Standard Deviation 59.92
Group 9 (RA)	Localization Intensity	180 ± 15 min L PIP4	198.6 TUV	Standard Deviation 85.67
Group 9 (RA)	Localization Intensity	180 ± 15 min L PIP5	168.3 TUV	Standard Deviation 58.47
Group 9 (RA)	Localization Intensity	60 ± 15 min L Shoulder	152.7 TUV	Standard Deviation 37.92
Group 9 (RA)	Localization Intensity	60 ± 15 min R Elbow	77.3 TUV	Standard Deviation 13.07
Group 9 (RA)	Localization Intensity	180 ± 15 min L MCP2	237.1 TUV	Standard Deviation 131.01
Group 9 (RA)	Localization Intensity	60 ± 15 min R PIP4	156.8 TUV	Standard Deviation 47.62
Group 9 (RA)	Localization Intensity	180 ± 15 min R Knee	151.8 TUV	Standard Deviation 25.49
Group 9 (RA)	Localization Intensity	60 ± 15 min L Knee	124.0 TUV	Standard Deviation 16.81
Group 9 (RA)	Localization Intensity	180 ± 15 min L MCP3	300.5 TUV	Standard Deviation 84.15
Group 9 (RA)	Localization Intensity	180 ± 15 min L Shoulder	181.4 TUV	Standard Deviation 66.68
Group 9 (RA)	Localization Intensity	60 ± 15 min R PIP5	170.5 TUV	Standard Deviation 103.26
Group 9 (RA)	Localization Intensity	60 ± 15 min R MCP2	286.1 TUV	Standard Deviation 114.89
Group 9 (RA)	Localization Intensity	60 ± 15 min L Elbow	72.1 TUV	Standard Deviation 4.87
Group 9 (RA)	Localization Intensity	180 ± 15 min R MCP1	416.8 TUV	Standard Deviation 194.14
Group 9 (RA)	Localization Intensity	180 ± 15 min R PIP1	262.7 TUV	Standard Deviation 83.66
Group 9 (RA)	Localization Intensity	180 ± 15 min R MCP4	363.7 TUV	Standard Deviation 104.49
Group 9 (RA)	Localization Intensity	180 ± 15 min R Wrist	456.8 TUV	Standard Deviation 194.99
Group 9 (RA)	Localization Intensity	180 ± 15 min L Knee	146.8 TUV	Standard Deviation 22.71
Group 9 (RA)	Localization Intensity	60 ± 15 min L PIP4	171.4 TUV	Standard Deviation 75.27
Group 9 (RA)	Localization Intensity	180 ± 15 min R MCP3	367.9 TUV	Standard Deviation 121.03
Group 9 (RA)	Localization Intensity	180 ± 15 min L Wrist	484.7 TUV	Standard Deviation 164.36
Group 9 (RA)	Localization Intensity	180 ± 15 min L MCP1	327.7 TUV	Standard Deviation 58.96
Group 9 (RA)	Localization Intensity	60 ± 15 min L MCP3	270.5 TUV	Standard Deviation 122.88
Group 9 (RA)	Localization Intensity	180 ± 15 min L MCP4	305.5 TUV	Standard Deviation 97.92
Group 9 (RA)	Localization Intensity	180 ± 15 min R MCP5	369.2 TUV	Standard Deviation 77.77
Group 9 (RA)	Localization Intensity	60 ± 15 min L PIP2	165.6 TUV	Standard Deviation 46.37
Group 9 (RA)	Localization Intensity	60 ± 15 min R MCP5	215.5 TUV	Standard Deviation 103.57
Group 9 (RA)	Localization Intensity	60 ± 15 min R PIP3	189.5 TUV	Standard Deviation 44.79
Group 9 (RA)	Localization Intensity	60 ± 15 min L PIP5	160.8 TUV	Standard Deviation 36.56
Group 9 (RA)	Localization Intensity	180 ± 15 min L Elbow	91.0 TUV	Standard Deviation 2.59
Group 9 (RA)	Localization Intensity	60 ± 15 min R PIP2	187.0 TUV	Standard Deviation 77.42
Group 9 (RA)	Localization Intensity	180 ± 15 min R PIP4	196.2 TUV	Standard Deviation 108.71
Group 9 (RA)	Localization Intensity	60 ± 15 min R Wrist	337.6 TUV	Standard Deviation 191.93
Group 9 (RA)	Localization Intensity	180 ± 15 min L PIP1	254.3 TUV	Standard Deviation 95.16
Group 9 (RA)	Localization Intensity	60 ± 15 min L PIP3	200.3 TUV	Standard Deviation 85.58
Group 9 (RA)	Localization Intensity	60 ± 15 min L Wrist	368.8 TUV	Standard Deviation 146.85
Group 9 (RA)	Localization Intensity	60 ± 15 min R MCP4	290.5 TUV	Standard Deviation 133.03
Group 9 (RA)	Localization Intensity	60 ± 15 min R Knee	133.7 TUV	Standard Deviation 22.82
Group 9 (RA)	Localization Intensity	60 ± 15 min L MCP2	248.3 TUV	Standard Deviation 132.4
Group 9 (RA)	Localization Intensity	180 ± 15 min R MCP2	340.5 TUV	Standard Deviation 169.41
Group 9 (RA)	Localization Intensity	180 ± 15 min R PIP2	225.4 TUV	Standard Deviation 9.65
Group 9 (RA)	Localization Intensity	180 ± 15 min R Shoulder	206.1 TUV	Standard Deviation 41.31
Group 9 (RA)	Localization Intensity	180 ± 15 min L PIP2	204.8 TUV	Standard Deviation 63.14

Secondary

Maximum Observed Concentration (Cmax)

Maximum observed concentration (Cmax) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.

Time frame: 15 minutes prior to administration. Immediately after administration. 15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post administration

Population: Only in Groups 10 and 11

Arm	Measure	Value (MEAN)
Group 10 (Healthy Controls)	Maximum Observed Concentration (Cmax)	1244.2 nCi/mL
Group 11 (RA)	Maximum Observed Concentration (Cmax)	2043.8 nCi/mL

Secondary

Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging

Tc 99m Tilmanocept localization is defined as the visually (i.e., qualitatively) determined binary categorization of Tc 99m tilmanocept activity in a given DAS28 joint. The purpose of the visual assessments is to obtain dichotomized classifications of tracer uptake (herein referenced as 'localization') on planar images. Per subject localization rate is the number of subjects with at least one localized DAS28 joint per number of subjects in the analysis population.

Time frame: For Groups 1-9, 60 ± 15 min or 180 ± 15 minute post injection planar and SPECT/CT images are used

Population: Subjects enrolled in Groups 10 and 11 received whole-body planar scans following Tc99 administration for PK and dosimetry analyses only.

Arm	Measure	Group	Value (NUMBER)
Group 1 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	60 ± 15 min	3 participants
Group 1 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	180 ± 15 min	3 participants
Group 2 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	180 ± 15 min	3 participants
Group 2 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	60 ± 15 min	3 participants
Group 3 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	60 ± 15 min	3 participants
Group 3 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	180 ± 15 min	3 participants
Group 4 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	60 ± 15 min	3 participants
Group 4 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	180 ± 15 min	3 participants
Group 5 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	60 ± 15 min	3 participants
Group 5 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	180 ± 15 min	3 participants
Group 6 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	60 ± 15 min	3 participants
Group 6 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	180 ± 15 min	3 participants
Group 7 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	180 ± 15 min	3 participants
Group 7 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	60 ± 15 min	3 participants
Group 8 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	60 ± 15 min	3 participants
Group 8 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	180 ± 15 min	3 participants
Group 9 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	180 ± 15 min	3 participants
Group 9 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging	60 ± 15 min	3 participants

Secondary

Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA

Per subject localization rate of Tc 99m tilmanocept in areas other than RA is defined as the number of subjects with at least one localized DAS28 joint per number of subjects in the analysis population.

Time frame: Imaging taken 60 ± 15 min and 180 ± 15 min post-injection

Population: Only Groups 1-9. Groups 10 \& 11 were not included in the population these endpoints were evaluated for.

Arm	Measure	Group	Value (NUMBER)
Group 1 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 60 ± 15 min	3 participants
Group 1 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 180 ± 15 min	3 participants
Group 2 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 60 ± 15 min	3 participants
Group 2 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 180 ± 15 min	3 participants
Group 3 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 60 ± 15 min	3 participants
Group 3 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 180 ± 15 min	3 participants
Group 4 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 60 ± 15 min	3 participants
Group 4 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 180 ± 15 min	3 participants
Group 5 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 60 ± 15 min	3 participants
Group 5 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 180 ± 15 min	3 participants
Group 6 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 180 ± 15 min	3 participants
Group 6 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 60 ± 15 min	3 participants
Group 7 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 180 ± 15 min	3 participants
Group 7 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 60 ± 15 min	3 participants
Group 8 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 60 ± 15 min	3 participants
Group 8 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 180 ± 15 min	3 participants
Group 9 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 60 ± 15 min	3 participants
Group 9 (RA)	Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA	Number of subjects localized at 180 ± 15 min	3 participants

Secondary

Radiation Dosimetry of Tc 99m Tilmanocept

Mean total radiation dose per organ (mSv/MBq) in HC females, HC males, females with active RA, and males with active RA. Results were obtained at the subject level from Hybrid Dosimetry™ Version 2.8.3 and OLINDA/EXM® Version 2.1RC93 in accordance with NAV3-21 Protocol Amendment 6. The Hybrid Dosimetry™ function provides an efficient way to generate kinetic data for selected organs via regions of interest (ROI) drawing. From this data, residence times are calculated and transferred to OLINDA/EXM®, which generates absorbed dose tables using the MIRD methodology.

Time frame: Planar images were taken 15 ± 5 minutes, 60 ± 5 minutes, 180 ± 5 minutes, 18 to 20 hours after Tc 99m tilmanocept administration and processed in accordance with the NAV3-21 protocol endpoints using established dosimetry software.

Population: Groups 10 and 11 will receive the maximum tested dose of 400 mcg tilmanocept radiolabeled with 10 mCi of Tc 99m at the MTD via IV injection.

Arm	Measure	Value (MEAN)	Dispersion
Group 10 (Healthy Controls)	Radiation Dosimetry of Tc 99m Tilmanocept	4.69 mSv/MBq	Standard Deviation 4.54
Group 11 (RA)	Radiation Dosimetry of Tc 99m Tilmanocept	2.69 mSv/MBq	Standard Deviation 1.13
Group 11 (RA Females)	Radiation Dosimetry of Tc 99m Tilmanocept	5.06 mSv/MBq	Standard Deviation 4.93
Group 11 (RA Males)	Radiation Dosimetry of Tc 99m Tilmanocept	3.02 mSv/MBq	Standard Deviation 2.97

Secondary

Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints

Per joint (clinically RA-identified) joint localization rate of Tc 99m tilmanocept is defined as the number of localized joints per number of joints from subjects in the analysis population Groups 1-9 using SPECT imaging.

Time frame: Whole-body planar scan at 60 ± 15 and 180 ± 15 minutes post Tc 99m tilmanocept administration with a duration of approximately 25 to 30 minutes at each timepoint.

Population: Groups 10 \& 11 were not included in the population these endpoints were evaluated for.

Arm	Measure	Category	Value (COUNT_OF_UNITS)
Group 1 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 3 hr	16 Joint
Group 1 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 1 hr	7 Joint
Group 2 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 3 hr	42 Joint
Group 2 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 1 hr	40 Joint
Group 3 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 3 hr	20 Joint
Group 3 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 1 hr	25 Joint
Group 4 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 3 hr	20 Joint
Group 4 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 1 hr	12 Joint
Group 5 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 3 hr	8 Joint
Group 5 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 1 hr	5 Joint
Group 6 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 1 hr	28 Joint
Group 6 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 3 hr	24 Joint
Group 7 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 1 hr	5 Joint
Group 7 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 3 hr	11 Joint
Group 8 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 3 hr	11 Joint
Group 8 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 1 hr	13 Joint
Group 9 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 3 hr	17 Joint
Group 9 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 1 hr	12 Joint
Group 10 (Healthy Controls)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 1 hr	0 Joint
Group 11 (RA)	Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints	Joint localization at 1 hr	0 Joint

Secondary

Time to Cmax (Tmax)

Time to Cmax (tmax) will be calculated, whenever possible, using Tc 99m tilmanocept total radioactivity in whole blood and urine.

Time frame: Radioactivity was quantitated at each time point -15 mins prior to administration• Immediately after administration •15 ± 5 minutes post administration • 60 ± 15 minutes post administration • 180 ± 15 minutes post administration • 18 to 20 hours post admi

Population: Groups 10 and 11

Arm	Measure	Value (MEAN)	Dispersion
Group 10 (Healthy Controls)	Time to Cmax (Tmax)	27.3 minutes	Standard Deviation 7.36
Group 11 (RA)	Time to Cmax (Tmax)	255 minutes	Standard Deviation 6.58

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Incidence of Adverse Drug Reaction

Apparent Terminal Elimination Half-life (t1/2)

Apparent Terminal Elimination Rate Constant (Z)

Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measureable Concentration (AUC0-t)

AUC Extrapolated to Infinity

Concordance

Localization Intensity

Maximum Observed Concentration (Cmax)

Per Subject Localization Rate of Tc 99m Tilmanocept by SPECT Imaging

Per Subject Localization Rate of Tc 99m Tilmanocept in Areas Other Than RA

Radiation Dosimetry of Tc 99m Tilmanocept

Tc 99m Tilmanocept Joint Localization Rate in Rheumatoid Arthritis Identified Joints

Time to Cmax (Tmax)