Clinical trial • Not applicable • Oncology|Gastroenterology
Girentuximab (labelled with Zirconium-89) for Gastroenteropancreatic neuroendocrine neoplasms|Hepatocellular carcinoma|Biliary tract cancer
Not applicable trial of Girentuximab (labelled with Zirconium-89) for Gastroenteropancreatic neuroendocrine neoplasms|Hepatocellular carcinoma|Biliary tra…
Overview
- Trial Therapeutic Area
- Oncology|Gastroenterology
- Trial Disease
- Gastroenteropancreatic neuroendocrine neoplasms|Hepatocellular carcinoma|Biliary tract cancer
- Trial Stage
- Not applicable
- Drug Modality
- Monoclonal antibody|Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 26-09-2024
- First CTIS Authorization Date
- 27-11-2024
Trial design
Not applicable trial across 5 sites in France.
- Target Sample Size
- 60
Eligibility
Recruits 60 Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on specific vulnerable groups, consent, or assent handling are provided in the record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on specific vulnerable groups, consent, or assent handling are provided in the record.
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 33
- Consent Approach
- Not specified in the record
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 60
France
- Earliest CTIS Part Ii Submission Date
- 12-11-2024
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 539
- Number Of Sites
- 5
- Number Of Participants
- 60
Sites
- Site Name
- Hopital Beaujon
- Department Name
- Gastro-entérologie et hépatologie
- Contact Person Name
- Louis de MESTIER
- Contact Person Email
- louis.demestier@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Nuclear Medecine
- Contact Person Name
- Clément BAILLY
- Contact Person Email
- clement.bailly@chu-nantes.fr
- Site Name
- Hopital Beaujon
- Department Name
- Nuclear Medecine
- Contact Person Name
- Rachida LEBTAHI
- Contact Person Email
- rachida.lebtahi@aphp.fr
- Site Name
- Hopital Beaujon
- Department Name
- Gastro-entérologie et hépatologie
- Contact Person Name
- Mohamed BOUATTOUR
- Contact Person Email
- mohamed.bouattour@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Institut des Maladies de l’Appareil Digestif
- Contact Person Name
- Yann TOUCHEFEU
- Contact Person Email
- yann.touchefeu@chu-nantes.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire De Nantes
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- 89Zirconium-labelled Girentuximab (89Zr-TLX250)
- Active Substance
- Girentuximab (labelled with Zirconium-89)
- Modality
- Monoclonal antibody|Radiopharmaceutical
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