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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Navidea Biopharmaceuticals

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.