Clinical trial • Phase I • Oncology
Lutetium-177 DOTA-TATE for Somatostatin receptor-positive tumours
Phase I trial of Lutetium-177 DOTA-TATE for Somatostatin receptor-positive tumours. 18 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Somatostatin receptor-positive tumours
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical|Small molecule
Key dates
- Initial CTIS Submission Date
- 24-09-2024
- First CTIS Authorization Date
- 23-10-2024
Trial design
Phase I trial across 1 site in Sweden.
- Target Sample Size
- 18
Eligibility
Recruits 18 Vulnerable populations not selected; no consent or assent information provided..
- Vulnerable Population
- Vulnerable populations not selected; no consent or assent information provided.
Recruitment
- Planned Sample Size
- 18
- Recruitment Window Months
- 101
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 18
Sweden
- Earliest CTIS Part Ii Submission Date
- 07-10-2024
- Latest Decision Or Authorization Date
- 23-10-2024
- Processing Time Days
- 16
- Number Of Sites
- 1
- Number Of Participants
- 18
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Oncology
- Principal Investigator Name
- Andreas Hallqvist
- Principal Investigator Email
- andreas.hallqvist@vgregion.se
- Contact Person Name
- Andreas Hallqvist
- Contact Person Email
- andreas.hallqvist@vgregion.se
- Number Of Participants
- 18
Sponsor
Primary sponsor
- Full Name
- Vaestra Goetalandsregionen
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- 177Lu-DOTA-TATE
- Active Substance
- Lutetium-177 DOTA-TATE
- Modality
- Radiopharmaceutical
- Investigational Product Name
- olaparib
- Active Substance
- olaparib
- Modality
- Small molecule
- Combination Treatment
- Yes
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