Using FAPI PET-CT to Improve Treatment for Proximal Cholangiocarcinoma
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
This study is testing if a new type of imaging called FAPI PET-CT can help doctors better plan treatment for patients with bile duct cancer by finding cancer spread more accurately than regular scans.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 81 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Amsterdam and 2 other locations) |
| Trial ID | NCT06355427 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for exploratory surgery for suspected proximal cholangiocarcinoma who are considered resectable based on current imaging.
Not a fit: Patients who have had previous abdominal surgery or chemotherapy, or those with contraindications for PET-CT, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate preoperative assessments and better treatment decisions for patients with proximal cholangiocarcinoma.
How similar studies have performed: Previous single-center studies have shown that FAPI PET-CT is superior to traditional imaging methods for detecting metastases in cholangiocarcinoma, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Amsterdam and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.