Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study on the Impact of [18F]-AlF-FAPI-74, Glucagon, and Hyoscine Butylbromide in Patients with Resectable Biliary Tract Cancer

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the management of patients with potentially resectable cholangiocarcinoma, a type of cancer that affects the bile ducts. The study will use a special imaging technique called [18F]F-FAPI PET-CT to see if it can provide more accurate information than the standard imaging methods used before surgery. The goal is to determine if this new imaging method can help doctors make better decisions about the treatment of patients with this type of cancer.

During the study, patients will undergo the [18F]F-FAPI PET-CT scan in addition to the usual imaging tests like CT (computed tomography) and MRI (magnetic resonance imaging). The study will compare the results of these imaging tests to see if the new method offers any advantages. The study will also look at how the imaging results affect the treatment plan and whether it leads to any changes in the management of the disease.

In addition to the main focus on imaging, the study will also involve the use of other medications such as GlucaGen® and Scopolamine butylbromide, which are solutions for injection. These medications are used for different purposes and will be administered as part of the study protocol. The study aims to gather information on the effectiveness and potential benefits of using the new imaging technique in combination with these treatments for patients with cholangiocarcinoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the tumor is considered resectable based on preoperative CT and MRI scans.

    Eligibility criteria include being scheduled for explorative laparoscopy or laparotomy due to suspicion of proximal cholangiocarcinoma, being 18 years or older, and being able to provide informed consent.

  2. Step 2

    Administration of [18F]-AlF-FAPI-74

    The patient receives an injection of [18F]-AlF-FAPI-74, a solution used for imaging purposes. This is administered intravenously.

    The purpose of this injection is to enhance the diagnostic accuracy of PET-CT scans in detecting potentially resectable bile duct cancer.

  3. Step 3

    PET-CT imaging

    Following the administration of the imaging agent, a PET-CT scan is performed. This scan provides detailed images that help in assessing the cancer's resectability.

    The results from this scan are compared with standard preoperative imaging to evaluate the effectiveness of the [18F]-AlF-FAPI-74.

  4. Step 4

    Administration of glucagon

    Glucagon is administered as a solution for injection. This is typically given to help manage blood sugar levels during the imaging process.

    The administration route is through an injection, which may be intravenous or intramuscular, depending on the specific requirements of the procedure.

  5. Step 5

    Administration of hyoscine butylbromide

    Hyoscine butylbromide is administered as a solution for injection to reduce muscle spasms during the imaging process.

    This medication is given intramuscularly to ensure patient comfort and improve the quality of the imaging results.

  6. Step 6

    Follow-up and analysis

    After the imaging procedures, the results are analyzed to determine the sensitivity, specificity, and predictive values of the PET-CT scan.

    Additional analyses include assessing any changes in treatment plans, cost-effectiveness, and the impact on health-related quality of life.

Who can join the trial?

3 criteria

  • The patient is scheduled for a procedure called **explorative laparoscopy** or **laparotomy**. These are types of surgeries where doctors look inside the abdomen to check for signs of a specific type of cancer called **proximal cholangiocarcinoma**. This cancer can affect areas like the bile ducts inside the liver, near the liver, or the gall bladder.
  • The tumor is considered **resectable**, meaning it can be removed through surgery, based on imaging tests like **CT** (a detailed X-ray) and **MRI** (a scan that uses magnets and radio waves to create pictures of the inside of the body) done before the surgery.
  • The patient is **18 years or older** and is able to understand the study and agree to participate by giving **informed consent**. This means they understand the details of the study and agree to take part.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with **cholangiocarcinoma**. This is a type of cancer that affects the bile ducts.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

[18F]F-FAPI PET-CT is a type of imaging test used in this clinical trial. It helps doctors see detailed pictures of the inside of the body, specifically focusing on areas where there might be cancer in the bile ducts. This test is being studied to see if it can provide more accurate information than the standard imaging tests usually done before surgery. The goal is to help doctors decide the best way to treat patients with bile duct cancer that might be removable by surgery.

What is already known about the treatment

[18F]F-FAPI – This medication is administered through a PET-CT scan, which is a type of imaging test. It is currently being studied in clinical trials to evaluate its effectiveness in diagnosing certain types of bile duct cancer, specifically cholangiocarcinoma. The main therapeutic indication is to improve the accuracy of cancer diagnosis, potentially aiding in surgical planning. At the molecular level, [18F]F-FAPI targets fibroblast activation protein, which is often present in cancerous tissues, allowing for better imaging contrast. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Cholangiocarcinoma – Cholangiocarcinoma is a type of cancer that forms in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. It can occur in different parts of the bile duct system, including intrahepatic (inside the liver), perihilar (where the bile ducts exit the liver), and distal (closer to the small intestine). The disease often progresses slowly and may not show symptoms until it is advanced. As it develops, it can cause jaundice, abdominal pain, and weight loss. The cancer can spread to nearby organs and tissues, complicating its progression. Early detection is challenging due to the deep location of the bile ducts and the subtlety of early symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507938-24-00Estimated enrolment81 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.