Trial Outcomes & Findings for Comparison of Tc 99m Tilmanocept Imaging With IHC Analysis of CD206 Expression in Synovial Tissue of Subjects With RA (NCT NCT04078191)

NCT ID: NCT04078191

Last Updated: 2025-01-08

Results Overview

The correlation between joint-specific tilmanocept uptake value (TUVjoint) and the number and area fraction of CD206 expression as determined by IHC assessment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Through study completion, up to 45 days

Results posted on

2025-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	RA Subjects on Stable Therapy RA subjects who are on stable treatment will receive a single dose of 150 mcg tilmanocept radiolabeled with 10 mCi Tc 99m. Tc 99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Tc 99m Tilmanocept Imaging With IHC Analysis of CD206 Expression in Synovial Tissue of Subjects With RA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RA Subjects on Stable Therapy n=20 Participants RA subjects who are on stable treatment will receive a single dose of 150 mcg tilmanocept radiolabeled with 10 mCi Tc 99m. Tc 99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants
Age, Categorical >=65 years	8 Participants n=99 Participants
Age, Continuous	59.0 years n=99 Participants
Sex: Female, Male Female	14 Participants n=99 Participants
Sex: Female, Male Male	6 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	15 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	13 participants n=99 Participants
Region of Enrollment United Kingdom	7 participants n=99 Participants

PRIMARY outcome

Timeframe: Through study completion, up to 45 days

Population: Data not collected.

The correlation between joint-specific tilmanocept uptake value (TUVjoint) and the number and area fraction of CD206 expression as determined by IHC assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion, up to 45 days

Population: Data not collected.

The correlation between TUVjoint and the number and area fraction of CD68 and CD163 determined by IHC assessments.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion, up to 45 days

Population: All enrolled subjects injected with Tc99m technetium

Classification of synovial anatomic pathology into * Lympho-myeloid * Diffuse myeloid * Pauci-immune fibroid types as a function of CD68, CD163, CD206, CD3, CD20, CD55, and TE7 expression determined by IHC assessments using a polytomous logistic regression model.

Outcome measures

Outcome measures
Measure	RA Subjects on Stable Therapy n=20 Participants RA subjects who are on stable treatment will receive a single dose of 150 mcg tilmanocept radiolabeled with 10 mCi Tc 99m. Tc 99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Classification of Synovial Anatomic Pathotype by IHC Assessment Diffuse/Myeloid	8 Participants
Classification of Synovial Anatomic Pathotype by IHC Assessment Pauci-immune/Fibroid	8 Participants
Classification of Synovial Anatomic Pathotype by IHC Assessment Lympho-Myeloid	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, up to 45 days

Population: Data not collected.

* Determine the relationship between TUVjoint and mRNA expression profiles of CD68, CD163, and CD206 as determined by RNA sequencing (RNA-seq). * Determine the relationship between TUVjoint and the number, size, and intensity of CD68, CD163, and CD206 as determined by (optional) flow cytometry. * Evaluate synovial expression of CD3, CD20, CD55, and TE-7 and CD206 in synovial tissue biopsy specimens. * Assessment of the relationship between TUVglobal and synovial anatomic pathology.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, up to 45 days

Population: All enrolled subjects injected with Tc99m technetium.

Evaluate safety through the examination of adverse event (AE) incidence.

Outcome measures

Outcome measures
Measure	RA Subjects on Stable Therapy n=20 Participants RA subjects who are on stable treatment will receive a single dose of 150 mcg tilmanocept radiolabeled with 10 mCi Tc 99m. Tc 99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Safety Evaluation - AEs Adverse Events	25 Adverse Events
Safety Evaluation - AEs Serious Adverse Events	1 Adverse Events

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, up to 45 days

Population: All enrolled subjects injected with Tc99m technetium.

Evaluate safety through physical examination findings, and changes over time in laboratory tests, electrocardiograms (ECGs), and vital signs.

Outcome measures

Outcome measures
Measure	RA Subjects on Stable Therapy n=20 Participants RA subjects who are on stable treatment will receive a single dose of 150 mcg tilmanocept radiolabeled with 10 mCi Tc 99m. Tc 99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Safety Evaluation - Laboratory Tests, ECGs, and Vital Signs Clinically Significant Laboratory Tests	0 Incidents
Safety Evaluation - Laboratory Tests, ECGs, and Vital Signs Clinically Significant ECG Readings	0 Incidents
Safety Evaluation - Laboratory Tests, ECGs, and Vital Signs Clinically Significant Vital Signs	0 Incidents

Adverse Events

RA Subjects on Stable Therapy

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RA Subjects on Stable Therapy n=20 participants at risk RA subjects who are on stable treatment will receive a single dose of 150 mcg tilmanocept radiolabeled with 10 mCi Tc 99m. Tc 99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Respiratory, thoracic and mediastinal disorders Covid	5.0% 1/20 • Number of events 1 • 1 year, 8 months

Other adverse events

Other adverse events
Measure	RA Subjects on Stable Therapy n=20 participants at risk RA subjects who are on stable treatment will receive a single dose of 150 mcg tilmanocept radiolabeled with 10 mCi Tc 99m. Tc 99m tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
Musculoskeletal and connective tissue disorders Pain	20.0% 4/20 • Number of events 6 • 1 year, 8 months
Immune system disorders Fever	5.0% 1/20 • Number of events 1 • 1 year, 8 months
Musculoskeletal and connective tissue disorders Swelling	30.0% 6/20 • Number of events 6 • 1 year, 8 months
Musculoskeletal and connective tissue disorders Bruising	25.0% 5/20 • Number of events 14 • 1 year, 8 months
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • 1 year, 8 months
Gastrointestinal disorders Nausea	10.0% 2/20 • Number of events 2 • 1 year, 8 months
Psychiatric disorders Trouble falling asleep	5.0% 1/20 • Number of events 1 • 1 year, 8 months
Cardiac disorders Palpitations	5.0% 1/20 • Number of events 1 • 1 year, 8 months
Nervous system disorders Dizziness	5.0% 1/20 • Number of events 2 • 1 year, 8 months

Additional Information

Michael Blue, MD

Navidea

Phone: 6145714313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Clinical Trail Agreement prevents any PIs to publish data that has not been approved by the sponsor.
Publication restrictions are in place

Restriction type: OTHER