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The Effect of [18F] F-FAPI PET-CT on Management in Patients With Proximal Cholangiocarcinoma

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllMara Veenstra, MD
NCT06355427 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background Bile duct cancer (cholangiocarcinoma) represents the second most common type of hepatobiliary cancer worldwide with an incidence of 0.35 to 2 per 100.000 annually. Currently, surgical resection is the only curative option. However, patients are not eligible for surgery if the tumor cannot be resected or the cancer has spread. For this group of patients, palliative chemotherapy is the most suited treatment option. To find out if a patient is suited for surgery, CT and MRI are performed. These imaging techniques, however, struggle to correctly identify small cancer spreads that are smaller than 1 cm. Therefore, cancer that has already spread can be found during surgery. In these cases, the tumor cannot be removed and the surgery therefore has not been of any benefit for the patient. These surgeries could be avoided by implementing a diagnostic tool with significantly higher acc

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📋 Eligibility rules (as published)
Inclusion 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 Exclusion Criteria: * 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)
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What it tests

  • [18F]F-FAPI PET-CT
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Where

3 sites
Amsterdam UMC
Amsterdam, Netherlands
Erasmus MC
Rotterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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