Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue of Subjects With Rheumatoid Arthritis (RA)

• Register: ClinicalTrials.gov
• Last refreshed on: 8 May 2023
• Main ID: NCT04078191
• Date of registration: 21/08/2019
• Prospective Registration: Yes
• Primary sponsor: Navidea Biopharmaceuticals
• Public title: Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue of Subjects With Rheumatoid Arthritis (RA)
• Scientific title: A Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue From Subjects Clinically Diagnosed With Rheumatoid Arthritis (RA)
• Date of first enrolment: September 14, 2021
• Target sample size: 24
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04078191
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United Kingdom, United States

Contacts

• Name: Michael Blue, MD
• Affiliation: Navidea Biopharmaceuticals

• Name: Michael Blue

Key inclusion & exclusion criteria

Inclusion Criteria:

1. The subject has provided written informed consent with HIPAA (Health Information
Portability and Accountability Act) or equivalent authorization before the initiation
of any study-related procedures.

2. Women and men of childbearing potential must use adequate birth control measures
(e.g., abstinence, oral contraceptives, intrauterine device, barrier method with
spermicide, or surgical sterilization) for the duration of the study.

3. The subject is at least 18 years of age and was = 18 years of age at the time of RA
diagnosis.

4. The subject has RA as determined by the 2010 American College of Rheumatology/European
League Against Rheumatism (ACR/EULAR) Classification Criteria (score of = 6/10 at or
before screening).

5. The subject has a 28-joint disease activity score (DAS28) of = 3.2 (includes the
C-reactive protein [CRP] test and visual analog scale [VAS]).

6. Subjects receiving traditional DMARDs must have been on therapy for = 90 days and at a
stable dose for = 30 days prior to the first imaging visit (Day 0).

7. If the subject is receiving biologic disease-modifying antirheumatic drug (bDMARD) or
janus kinase (JAK) inhibitor therapy, they have been at a stable dose > 180 days prior
to the first imaging visit (Day 0).

8. If the subject is receiving NSAIDs (nonsteroidal anti-inflammatory drug) or oral
corticosteroids, the dose has been at a stable dose for = 28 days prior to imaging.
The corticosteroid dose should be = 10 mg/day of prednisone or an equivalent steroid
dose.

9. The subject has a hand or wrist joint with a minimum ultrasound gray-scale synovitis
score of 2 (range 0 to 3).

Exclusion Criteria:

1. The subject is pregnant or lactating.

2. The subject size or weight is not compatible with imaging per the investigator.

3. The subject has had or is currently receiving radiation therapy or chemotherapy.

4. The subject has renal insufficiency as demonstrated by a glomerular filtration rate of
< 60 mL/min.

5. The subject has hepatic insufficiency as demonstrated by ALT (alanine aminotransferase
[SGPT]) or AST (aspartate aminotransferase [SGOT]) greater than 3 times the upper
limit of normal.

6. The subject has any severe, acute, or chronic medical conditions and/or psychiatric
conditions and/or laboratory abnormalities that would impart, in the judgment of the
investigator, excess risk associated with study participation or study drug
administration that would deem the subject inappropriate for study participation.

7. The subject has a known allergy to or has had an adverse reaction to dextran exposure.

8. The subject has received an investigational product within 30 days prior to the Tc 99m
tilmanocept administration (Day 0).

9. The subject has received intra-articular corticosteroids = 8 weeks prior to imaging
(Day 0).

10. The subject has received any radiopharmaceutical within 7 days or 10 half-lives prior
to the administration of Tc 99m tilmanocept (Day 0).

11. The subject has an intolerance to anesthetic and antiseptic agents indicated for the
synovial biopsy procedure.

12. The subject is currently receiving anticoagulants (oral anti-platelet agents are
permitted) or has a condition that is contraindicated with ultrasound-guided synovial
biopsy e.g., needle phobia.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Tc 99m tilmanocept

Primary Outcome(s)

Correlation between joint-specific tilmanocept uptake and CD206 expression [Time Frame: Through study completion, up to 45 days]

Secondary Outcome(s)

Correlation between CD206, CD68, and CD163 expression [Time Frame: Through study completion, up to 45 days]

Correlation between joint-specific tilmanocept uptake and CD68 and CD163 expression [Time Frame: Through study completion, up to 45 days]

Classification of synovial anatomic pathotype by IHC assessment [Time Frame: Through study completion, up to 45 days]

Secondary ID(s)

NAV3-32

2018-003418-41

Source(s) of Monetary Support

Please refer to primary and secondary sponsors