Clinical trial • Phase I • Other
DOTA-SIGLEC-9 labelled with Gallium-68 for Rheumatoid arthritis | Vasculitis | Pulmonary sarcoidosis
Phase I trial of DOTA-SIGLEC-9 labelled with Gallium-68 for Rheumatoid arthritis | Vasculitis | Pulmonary sarcoidosis. 26 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Rheumatoid arthritis | Vasculitis | Pulmonary sarcoidosis
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 25-11-2024
- First CTIS Authorization Date
- 29-01-2025
Trial design
Phase I trial across 1 site in Finland.
- Target Sample Size
- 26
Recruitment
- Planned Sample Size
- 26
- Recruitment Window Months
- 131
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 26
Finland
- Earliest CTIS Part Ii Submission Date
- 25-11-2024
- Latest Decision Or Authorization Date
- 29-01-2025
- Processing Time Days
- 65
- Number Of Sites
- 1
- Number Of Participants
- 26
Sites
- Site Name
- Turku University Hospital
- Department Name
- PET Centre
- Contact Person Name
- ANNE ROIVAINEN
- Contact Person Email
- anne.roivainen@utu.fi
- Number Of Participants
- 26
Sponsor
Primary sponsor
- Full Name
- Turku University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- [68Ga]Ga-DOTA-SIGLEC-9
- Active Substance
- DOTA-SIGLEC-9 labelled with Gallium-68
- Modality
- Radiopharmaceutical
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Investigational
- Frequency
- Single administration
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