An interventional study of [68Ga]Ga-DOTA-Siglec-9 in Healthy Subjects, Rheumatoid Arthritis and Vasculitis, sponsored by Turku University Hospital. Enrolling by invitation at 1 site in Finland. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Turku University Hospital · Not applicable, Interventional, and Other
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.
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.
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's planned enrollment of 26 is below the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Turku University Hospital is the lead sponsor of 286 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Intravenous 140 MBq bolus injection of \[68Ga\]Ga-DOTA-Siglec-9 radiopharmaceutical
Other: [68Ga]Ga-DOTA-Siglec-9
Vascular Adhesion Protein 1 (VAP-1) targeted radiopharmaceutical
Whole-body distribution of [68Ga]Ga-DOTA-Siglec-9
Knowledge how intravenously injected \[68Ga\]Ga-DOTA-Siglec-9 is distributed in human body
Time frame: within a day
Radiation dosimetry of [68Ga]Ga-DOTA-Siglec-9
Absorbed ionisation radiation dose in critical organs due to single intravenous 140 megabecquerel injection of \[68Ga\]Ga-DOTA-Siglec-9
Time frame: within a week
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