NCT03755245Enrolling by invitation
Biodistribution, Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With Rheumatoid Arthritis, Vasculitis or Pulmonary Sarcoidosis
PET/CT Study of Biodistribution and Performance of the [68Ga]Ga-DOTA-Siglec-9 in Patients With Rheumatoid Arthritis,Vasculitis or Pulmonary Sarcoidosis, and Radiation Dosimetry, Pharmacokinetics, Biodistribution, Safety and Tolerability in Healthy Men
Source: ClinicalTrials.gov · Last updated 25 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 23 Nov 2018
- Start date
- 23 Nov 2018
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Turku University Hospital
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT03755245
What you commit to
- Study type: Interventional
- Planned participants: 26
- From 23 Nov 2018 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- In healthy: ongoing infection/inflammation proven by blood or other tests
Who the study is looking for
- Healthy 18-70 year-old men
- Male or female 18-70 year-old patients with active rheumatoid arthritis, vasculitis or pulmonary sarcoidosis
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Turku University Hospital, Turku PET Centre Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
Related publications
- Proof-of-concept PET imaging of pulmonary sarcoidosis using VAP-1-targeted radiotracer [68Ga]Ga-DOTA-Siglec-9.Respir Res · 2025 · PMID 41420234
This page is information, not medical advice. Discuss any trial with your doctor.