Clinical trial • Phase IV • Oncology|Haematology
18F-Fluorocholine for Multiple myeloma
Phase IV trial of 18F-Fluorocholine for Multiple myeloma.
Overview
- Trial Therapeutic Area
- Oncology|Haematology
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase IV
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 24-07-2024
- First CTIS Authorization Date
- 23-08-2024
Trial design
18F-Fluorocholine (FCH) PET/CT versus 18F-Fluorodesoxyglucose (FDG) PET/CT; doses/schedules not specified-controlled Phase IV trial across 3 sites in France.
- Comparator
- 18F-Fluorocholine (FCH) PET/CT versus 18F-Fluorodesoxyglucose (FDG) PET/CT; doses/schedules not specified
- Target Sample Size
- 38
Eligibility
Recruits 38 No vulnerable populations selected (isVulnerablePopulationSelected: false). No information on consent/assent provided..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). No information on consent/assent provided.
Recruitment
- Planned Sample Size
- 38
- Recruitment Window Months
- 120
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 38
France
- Earliest CTIS Part Ii Submission Date
- 31-07-2024
- Latest Decision Or Authorization Date
- 23-08-2024
- Processing Time Days
- 23
- Number Of Sites
- 3
- Number Of Participants
- 38
Sites
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- 21
- Principal Investigator Name
- Clément DROUET
- Principal Investigator Email
- cldrouet@cgfl.fr
- Contact Person Name
- Clément DROUET
- Contact Person Email
- cldrouet@cgfl.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- 21
- Principal Investigator Name
- Jean-Noel BASTIE
- Principal Investigator Email
- Jean-noel.bastie@chu-dijon.fr
- Contact Person Name
- Jean-Noel BASTIE
- Contact Person Email
- Jean-noel.bastie@chu-dijon.fr
- Site Name
- CHU Besancon
- Department Name
- 25
- Principal Investigator Name
- Jean FONTAN
- Principal Investigator Email
- jfontan@chu-besancon.fr
- Contact Person Name
- Jean FONTAN
- Contact Person Email
- jfontan@chu-besancon.fr
Sponsor
Primary sponsor
- Full Name
- Centr Georges Francois Leclerc
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- 18F-Fluorocholine (FCH)
- Active Substance
- 18F-Fluorocholine
- Modality
- Radiopharmaceutical
- Investigational Product Name
- 18F-Fluorodesoxyglucose (FDG)
- Active Substance
- 18F-Fluorodeoxyglucose
- Modality
- Radiopharmaceutical
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