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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.
EU CTIS ID: 2023-507938-24-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Previous abdominal surgery or chemotherapy
- 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
- Known allergic reaction to therapeutic radiopharmaceuticals
See the full eligibility criteria
- 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
- Previous abdominal surgery or chemotherapy
- 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
- Known allergic reaction to therapeutic radiopharmaceuticals
- Inability to lie still on the back for the duration of PET-CT
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.