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

3 1 1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Arfhgmfwc Uwn	Amsterdam	The Netherlands
Evenxul Uroumqulmwmc Mpzqsey Crgblde Rtgdlwzem (zcdwzht Mlj	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.02.2024

Trial locations

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.

Investigated diseases:

Cholangiocarcinoma

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 ID:

2023-507938-24-00

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?