2023-507938-24-00RecruitingPhase 3
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- First submitted
- 14 Nov 2023
- Start date
- 29 Nov 2024
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Liver and biliary tract cancer
- EU CT number
- 2023-507938-24-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 81
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous abdominal surgery
Other illness
- Known allergic reaction to therapeutic radiopharmaceuticals
Lab values
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC | Amsterdam | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.