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New treatment option for Cholangiocarcinoma
Official title The Effect of [18F] F-FAPI PET-CT on Management in Patients With Proximal Cholangiocarcinoma
ClinicalTrials.gov ID: NCT06355427
What this study is testing
What is [18F]F-FAPI PET-CT?
[18F]F-FAPI PET-CT is an investigational medicine, given as an once-weekly, being studied as a potential treatment for cholangiocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient is scheduled for explorative laparoscopy or laparotomy for suspicion of proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder...
- Tumor is regarded as resectable based on preoperative CT and MRI
- Patient is 18 years or older and is able to give informed consent
You likely can't join if
- 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
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Rotterdam, Netherlands
- Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands; Rotterdam, Netherlands; Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.