Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging

NCT02683421 | Completed Phase 1 Results

• 1 other identifier: NAV3-23
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

Determine the localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with active RA and concordance with clinical symptomology.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Tilmanocept; Imaging

Outcome Measures

Primary Outcomes (1)

• Localization of Tc 99m Tilmanocept by Planar and SPECT/CT Imaging in Subjects With Active RA and Concordance With Swollen/Tender Joints

  The primary endpoint was to compare the cumulative total of anatomical zones of active RA (which were clinically defined by a swollen/tender classification during the DAS28 joint count assessment performed at baseline) with Tc 99m tilmanocept localization observed at 2-3 hours and at 4-6 hours after administration on Day 1. Tc 99m tilmanocept localization is defined by accumulation of radioactivity at an intensity greater than background, which was qualitatively determined by the central reader's visual assessment of the acquired images .

  Swollen/tender joints assessment at baseline and Tc 99m tilmanocept localization at 2-3 hours and 4-6 hours after administration on Day 1

Secondary Outcomes (2)

• Dose-dependent Tc 99m Tilmanocept Localization Intensity by Planar and SPECT/CT Imaging

  2-4 hours and 4-6 hours

• Localization Intensity of Tc 99m Tilmanocept by Planar Imaging in Regions of Interest Relative to Background in All Dose Groups

  2-4 hours and 4-6 hours

Study Arms (4)

Cohort 1

OTHER

Healthy Volunteers: 50 mcg tilmanocept with 2 millicuries (mCi) Tc 99m

Drug: Tilmanocept

Cohort 2

OTHER

Healthy Volunteers: 200 mcg tilmanocept with 2 mCi Tc 99m

Drug: Tilmanocept

Cohort 3

EXPERIMENTAL

RA Group: 50 mcg tilmanocept with 2 mCi Tc 99m

Drug: Tilmanocept

Cohort 4

EXPERIMENTAL

RA group:200 mcg tilmanocept with 2 mCi Tc 99m

Drug: Tilmanocept

Interventions

Tilmanocept DRUG

Also known as: Lymphoseek

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has provided written informed consent with HIPPA authorization before the initiation of any study-related procedures.
• CONTROLS:
• The subject is between 21-45 years of age at the time of consent.
• The subject has not experienced joint pain for at least 4 weeks prior to the consent date and is deemed to be clinically free of any inflammatory disease(s).
• ACTIVE RHEUMATOID ARTHRITIS
• The subject is at least 21 years of age at the time of consent.
• The subject has moderate to severe RA, based on either the 1987American College of Rheumatology (ACR) score of ≥ 4/7 or the 2010 ACR/EULAR score of ≥ 6/10.
• The subject has a DAS28 of \>4.4 (using the ESR).
• If the subject is on methotrexate, they have been at a stable dose for \> 4 weeks prior to the screening visit.
• If the subject is on biologic therapy, they have been at a stable dose \> 8 weeks prior to the screening visit.
• If the subject is on non-steroidal anti-inflammatories (NASIDS) or oral corticosteroids, it is ≤ 10mgmg/day or equivalent, and has been at a stable dose for \> 4 weeks prior to the screening visit.

You may not qualify if:

• The subject is pregnant or lactating.
• BMI \>32.0.
• The subject has had or is currently receiving chemotherapy for a non-inflammatory related condition or radiation therapy.
• 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 a reaction to dextran exposure.
• The subject has received an investigational product within 30 days prior to he Tc99m tilmanocept administration.
• The subject has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical prior to the administration of Tc 99m tilmanocept.

Sponsors & Collaborators

• Navidea Biopharmaceuticals: lead

Study Sites (2)

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Bonnie C. Abbruzzese, MS, RD
• Organization: Navidea Biopharmaceuticals

babbruzzese@navidea.com

614-822-2327

Study Officials

• Michael Blue, MD

  Navidea Biopharmaceuticals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 17, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 21, 2019
• Results First Posted: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)