The effect of [18F]F-FAPI PET-CT on management in patients with potentially resectable biliary tract cancers: prospective multicenter study and cost-effectivity analysis.
Key facts
- Where
- Amsterdam, Rotterdam és Utrecht, HollandiaSee the 3 sites
- Phase
- 3. fázis
Where in Hollandia
- Amsterdam UMCAmsterdam, HollandiaTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaTaking people
- Universitair Medisch Centrum UtrechtUtrecht, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- EU 2023-507938-24-00
- Record updated
- 2026. október 28.
- Original description
The primary aim of this study is to assess the diagnostic accuracy of [18F]F-FAPI PET-CT in addition to standard preoperative imaging in patients with potentially resectable proximal bile duct cancer (intrahepatic, perihilar and gall bladder cholangiocarcinoma).Read full original descriptionShow less
The primary aim of this study is to assess the diagnostic accuracy of [18F]F-FAPI PET-CT in addition to standard preoperative imaging in patients with potentially resectable proximal bile duct cancer (intrahepatic, perihilar and gall bladder cholangiocarcinoma).
Inclusion: Patient is scheduled for explorative laparoscopy or laparotomy for suspicion of proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder cholangiocarcinoma); Tumor is regarded as resectable based on preoperative CT and MRI; Patient is 18 years or older and is able to give informed consent.
Exclusion: Previous abdominal surgery; Known allergic reaction to therapeutic radiopharmaceuticals; Impaired renal function, defined as eGFR (MDRD) <25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician; Any (other) condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may affect the interpretation of the results, or which might contribute substantially to the patient's experience of study burden (such as non-suppressible claustrophobia); Patient had FDG PET-CT in addition to preoperative CT and MRI; Contra-indication for performing PET-CT; Indication for FDG PET-CT; Pregnancy or lactation, for the latter, temporary discontinuation may be considered; Inability to lie still on the back for the duration of PET-CT.