Biodistribution, Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With Rheumatoid Arthritis, Vasculitis or Pulmonary Sarcoidosis
Launched by TURKU UNIVERSITY HOSPITAL · Nov 23, 2018
Trial Information
Current as of November 08, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This study is testing a new imaging tracer called [68Ga]Ga-DOTA-Siglec-9 to see how safe it is, how it behaves in the body, and how well it highlights areas of inflammation on PET scans. It’s a first-in-human study, meaning it’s among the first times this tracer is used in people. Researchers will look at where the tracer goes in the body (biodistribution), how the body processes it (pharmacokinetics), and the amount of radiation absorbed by organs (dosimetry), as well as whether people tolerate it well.
Adults aged 18 to 70, including healthy volunteers and people with active rheumatoid arthritis, vasculitis, or pulmonary sarcoidosis, may be eligible. If you participate, you would receive a single intravenous injection of the tracer, followed by PET/CT imaging on the same day to observe distribution, plus safety monitoring and radiation-dose measurements within the first week. The study is led by Turku University Hospital in Finland, and it is currently enrolling by invitation with the goal of completion around 2025; results have not yet been reported in this record.
Gender
ALL
Eligibility criteria
- 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
About Turku University Hospital
Turku University Hospital (TYKS) is a leading academic medical center located in Turku, Finland, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a key institution within the University of Turku, TYKS integrates cutting-edge medical education with state-of-the-art clinical services, offering a broad spectrum of specialized care. The hospital actively participates in clinical trials, facilitating the translation of scientific discoveries into practical treatments, and enhancing patient outcomes. With a multidisciplinary approach and a focus on collaboration, TYKS aims to contribute significantly to the global medical community through its rigorous research initiatives and commitment to patient-centered care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Turku, Finland
Patients applied
Trial Officials
Anne Roivainen, Professor
Principal Investigator
Turku University Hospital, Turku PET Centre
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials