Biodistribution, Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With… (NCT03755245) | Clinical Trial Compass
By InvitationNot Applicable
Biodistribution, Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With Rheumatoid Arthritis, Vasculitis or Pulmonary Sarcoidosis
Finland26 participantsStarted 2018-11-23
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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