Using FAPI PET-CT to Improve Treatment for Proximal Cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of [18F]F-FAPI PET-CT imaging in managing patients with proximal cholangiocarcinoma, a type of bile duct cancer. The study aims to determine if this advanced imaging technique can more accurately identify metastases compared to standard imaging methods like CT and MRI. By potentially altering treatment plans for patients deemed resectable based on traditional imaging, the trial seeks to improve surgical outcomes and reduce unnecessary surgeries. The study involves patients scheduled for exploratory surgery and assesses the impact of FAPI PET-CT on their treatment course.

Why it matters

Who can join: the full rules

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)

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• Erasmus MC
  Rotterdam, Netherlands Recruiting
• UMC Utrecht
  Utrecht, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Mara Veenstra, M.D.
• Email: m.m.k.veenstra@erasmusmc.nl
• Phone: +31 (0)10 704 2006

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.