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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

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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)
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Amsterdam UMCAmsterdamNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)RotterdamNetherlandsRecruiting
Universitair Medisch Centrum UtrechtUtrechtNetherlandsRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.