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Taking people in NetherlandsPhase 3

Tests a new PET scan in people with bile duct cancer

Tests a PET scan alongside usual imaging in adults with bile duct cancer.

Key facts

Who runs it
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Where
Amsterdam, Rotterdam, and Utrecht, NetherlandsSee the 3 sites
Registry title
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.
Status
Recruiting
Phase
Phase 3
People taking part
81 people, planned
Started
29 Nov 2024
Planned end
1 Sept 2024
Type of study
Interventional
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who are scheduled for an exploratory operation because a cancer of the bile ducts or gall bladder is suspected and the tumour looks removable on CT and MRI.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Suspected proximal bile duct cancer (perihilar, intrahepatic or gall bladder cholangiocarcinoma). The tumour is seen as resectable on CT and MRI before surgery.
Earlier treatment
No previous abdominal surgery. No FDG PET-CT in addition to the CT and MRI done before surgery.

Main reasons for not taking part

  • Previous abdominal surgery
  • Pregnancy or breastfeeding
  • Reduced kidney function (eGFR below 25 ml/min/1,73 m2)
  • Cannot lie still on the back during the PET-CT scan
  • Known allergic reaction to therapeutic radiopharmaceuticals

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Netherlands

  • Amsterdam UMCAmsterdam, NetherlandsTaking people
  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
  • Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people

About the trial

What the trial wants to find out

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).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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.
Plain-language title
Tests a new PET scan in people with bile duct cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
28 October 2026