Biodistribution Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With Rheumatoid Arthritis Vasculitis or Pulmonary Sarcoidosis

  • STATUS
    Recruiting
  • days left to enroll
    24
  • participants needed
    26
  • sponsor
    Turku University Hospital
Updated on 19 June 2021
vasculitis
pulmonary sarcoidosis

Summary

This study evaluates safety, tolerability, biodistribution and performance of the [68Ga]Ga-DOTA-Siglec-9 following a single intravenous administration in patients with active rheumatoid arthritis, vasculitis or pulmonary sarcoidosis as well as radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and tolerability of the tracer in healthy volunteers.

Description

Vascular adhesion protein 1 (VAP-1) is an inflammation inducible endothelial cell molecule mediating leukocyte trafficking from blood into the sites of inflammation. Although VAP-1 plays important role in early phases of inflammation, its luminal expression on the endothelium will remain constant if the inflammation continues, which suggest VAP-1 as a promising target for molecular imaging of inflammation. We have previously shown that sialic acid-binding immunoglobulin-like lectin 9 (Siglec-9) is a VAP-1 ligand, and the gallium-68 labeled 1,4,7,10-tetraazacyclododecane-N,N,N,N-tetraacetic acid conjugated peptide ([68Ga]Ga-DOTA-Siglec-9) containing residues 283-297 from Siglec-9 can be used for PET imaging of inflammation in various experimental models. This first-in-human study evaluates safety, tolerability, biodistribution and performance of [68Ga]Ga-DOTA-Siglec-9 after single intravenous injection in six healthy volunteers, and in ten patients with active rheumatoid arthritis (RA), five patients with vasculitis and five patients with pulmonary sarcoidosis.

Details
Condition Pulmonary sarcoidosis, Vascular Diseases, sarcoidosis, pulmonary, Rheumatoid Arthritis, Healthy Subjects, Rheumatoid Arthritis (Pediatric), Sarcoidosis, Vasculitis
Treatment [68Ga]Ga-DOTA-Siglec-9
Clinical Study IdentifierNCT03755245
SponsorTurku University Hospital
Last Modified on19 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy 18-70 year-old men
Male or female 18-70 year-old patients with active rheumatoid arthritis, vasculitis or pulmonary sarcoidosis

Exclusion Criteria

In healthy: ongoing infection/inflammation proven by blood or other tests
In patients with rheumatoid arthritis: no treatment with disease-modifying anti-rheumatic drugs or biologic agents, and no corticosteroids for 2 weeks prior the study
In patients with vasculitis: no immunosuppressives, and glucocorticoid less than 60 mg for 2 weeks or NSAIDs for 1 day prior the study
In patients with pulmonary sarcoidosis: no corticosteroids for 1 week or NSAIDs for day prior the study
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