Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging

• Register: ClinicalTrials.gov
• Last refreshed on: 4 September 2023
• Main ID: NCT03938636
• Date of registration: 24/04/2019
• Prospective Registration: No
• Primary sponsor: Navidea Biopharmaceuticals
• Public title: Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging
• Scientific title: Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging
• Date of first enrolment: April 8, 2019
• Target sample size: 116
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03938636
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

ALL SUBJECTS:

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

2. ARMS 1 and 2 (only): The subject has agreed to not engage in any diet, lifestyle, or
medication changes until study completion.

HEALTHY CONTROL SUBJECTS

3. The subject is between 18 and 80 years of age at the time of consent.

4. The subject is deemed to be clinically free of any inflammatory disease(s) and has not
experienced joint pain for at least 28 days prior to the consent date.

5. The subject is not currently on anti-inflammatory drugs (including NSAIDs) and has not
taken anti-inflammatories for at least 28 days prior to the consent date.

6. For all ongoing concomitant medications, the subject has maintained a stable dose for
at least 28 days prior to the consent date.

CLINICALLY DIAGNOSED ACTIVE RA SUBJECTS:

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 moderate to severe RA as determined by the 2010 American College of
Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria (score
of = 6/10).

5. The subject has a 28-joint disease activity score (DAS28) of = 3.2 (includes the
Erythrocyte Sedimentation Rate [ESR] 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 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 or oral corticosteroids, the dose has been stable for
> 28 days prior to first imaging visit (Day 1). The corticosteroid dose must be = 10 mg/day
of prednisone or an equivalent steroid dose.

9. ARM 3 (only): The subject is receiving anti-rheumatic treatment and is a candidate for
initiation of, or change to, a new anti-TNFa bDMARD treatment.

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.

9. The subject has received intra-articular corticosteroid injections = 8 weeks prior to
the first imaging visit (Day 0).

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



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)

Arms 1 & 2: Assess Camera-specific Precision of TUV [Time Frame: Day 0 tilmanocept injection followed by imaging at 60 minutes (60A) and 75 minutes (60B) and at 180 minutes (180A) and 195 minutes (180B).]

Longitudinal (8-day) Variation of TUV [Time Frame: Imaging (60 minutes after tilmanocept injection) on Day 0 and Day 8]

Arm 3: Correlation of ?TUVglobal[5w] and Response to Therapy [Time Frame: Imaging (60 minutes after tilmanocept injection) on Day 0 and at 5 weeks after new therapy initiation; Assessment of CDAI and ACR Response Criteria at 12 and 24 weeks after new therapy initiation.]

Arms 1 and 2: Stability of the Mean/Variance Relationship [Time Frame: Day 0 tilmanocept injection followed by imaging at 60 minutes and 180 minutes.]

Secondary Outcome(s)

Qualitative Evaluations of SPECT/CT as an Indication of Bone Involvement Rather Than Localization Within the Synovial Space in the Hands and Wrists of Arm 2 Subjects [Time Frame: A SPECT/CT scan was performed at approximately 210 minutes after the tilmanocept injection on Day 8 of the trial.]

Arm 1 Normal Ranges of TUVjoint [Time Frame: Images obtained 60 minutes after tilmanocept injection on Day 0.]

Arm 3 (Correlation of TUVglobal[Baseline] and Response to Therapy) [Time Frame: Images were obtained 60 minutes after tilmanocept injection on Day 0. New anti-TNFa therapy was initiated after completion of Day 0 procedures. CDAI and ACR were assessed on Day 0 and again 12 and 24 weeks after initiation of new anti-TNFa therapy.]

Secondary ID(s)

NAV3-31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/08/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03938636