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Title: Evaluation of Gallium-68 FAPI-46 PET Imaging for Better Detection and Monitoring of Pancreatic Cancer and Bile Duct Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on improving the detection and monitoring of pancreatic cancer and bile duct cancer using a special imaging technique called positron emission tomography (PET). The study uses a radioactive substance called Gallium-68 FAPI-46, which is given through a vein to create detailed pictures of cancer cells in the body.

The purpose of this research is to determine how well this new imaging method works in finding and measuring cancer in the pancreas and bile ducts, and how reliable it is when used repeatedly. The study is divided into three parts: the first part looks at how the imaging substance moves through the body, the second part tests how consistent the results are when the scan is repeated, and the third part examines how accurate the method is in detecting cancer and monitoring treatment response.

During the study, participants will receive intravenous injections of the imaging substance and undergo PET/CT scans. Some participants may have multiple scans to test how well the imaging technique works over time. The maximum amount of radioactive substance used in each scan is 345 megabecquerels (a unit used to measure radioactivity), and the imaging procedure typically takes place within one day.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial PET scan preparation

    You will receive an intravenous injection of a special imaging substance called Gallium-68 FAPI-46

    This substance helps create detailed images of pancreatic or bile duct cancer using a special camera called a PET/CT scanner

  2. Step 2

    Scanning procedure - Part A

    If your tumor is at least 20mm in size, you will undergo a detailed scanning session to analyze how the imaging substance moves through your body

    Multiple images will be taken to determine the best timing and method for future scans

  3. Step 3

    Repeat scanning - Part B

    If you participate in Part B, you will have two separate scans on different days

    No treatment will be given between these two scans

    The purpose is to check if the scan results are consistent when repeated

  4. Step 4

    Treatment monitoring - Part C

    If you have confirmed pancreatic cancer and are scheduled for pre-surgery treatment, you will receive scans to monitor your condition

    The scans will help evaluate how well the treatment is working

    Images will be compared with other types of scans you may receive, such as CT or MRI

  5. Step 5

    Follow-up evaluation

    Your scan results will be compared with tissue samples and other test results

    The images will be used to assess if surgery is possible and to evaluate treatment effectiveness

Who can join the trial?

6 criteria

  • Must be 18 years or older
  • Must provide written informed consent (formal agreement to participate in the study) before registration
  • For Part A: Must have pancreaticobiliary cancer (cancer of the pancreas or bile ducts) with a tumor measuring at least 20mm on CT scan
  • For Part B: Must have pancreatic cancer with a tumor measuring at least 20mm on CT scan. Cannot receive any treatment between required scans
  • For Part C: Must have pancreatic ductal adenocarcinoma (a specific type of pancreatic cancer) that has been confirmed through tissue examination and be eligible for neoadjuvant therapy (treatment given before surgery) followed by surgical removal
  • Both men and women can participate in the study

Who cannot join the trial?

11 criteria

  • Age below 18 years or above 90 years
  • Pregnant or breastfeeding women
  • Known allergy or hypersensitivity to the study medication or its components
  • Unable to lie still for approximately 60 minutes during the PET/CT scan (a medical imaging test that combines two types of scans)
  • Weight exceeding 150 kg (330 lbs) due to scanner table limitations
  • Participation in another clinical trial within the past 30 days
  • Mental conditions that prevent providing informed consent
  • Severe kidney dysfunction (as the study medication is cleared through kidneys)
  • History of other cancers in the past 5 years (except adequately treated non-melanoma skin cancer)
  • Life expectancy less than 3 months
  • Any medical condition that, in the opinion of the study doctor, makes participation unsafe
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  • Responsive

    Amsterdam UMC

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

[68Ga]Ga-FAPI-46 is a radioactive tracer used in positron emission tomography (PET) imaging. This substance helps doctors see cancer cells in the body, particularly in pancreatic and biliary tract cancers. When injected into the body, it attaches to specific proteins that are often found in higher amounts in cancer tissues. The imaging procedure helps doctors to detect cancer and monitor how well treatment is working. The tracer is used together with a PET/CT scanner to create detailed images of the body, allowing doctors to see where cancer might be present and how it may be spreading. This is particularly helpful for seeing pancreatic cancer and determining if it has spread to lymph nodes or other parts of the body.

What is already known about the treatment

[68Ga]Ga-FAPI-46 – A radioactive diagnostic imaging agent administered intravenously for Positron Emission Tomography (PET) scanning, specifically developed for detecting pancreatic cancer and bile duct cancer (cholangiocarcinoma). This radiopharmaceutical targets and binds to fibroblast activation protein (FAP), which is highly expressed in cancer-associated fibroblasts, allowing for detailed visualization of tumor tissue. The substance is currently being evaluated in clinical trials to assess its pharmacokinetics, repeatability, and diagnostic accuracy in detecting primary pancreatic ductal adenocarcinoma and its metastases, representing a promising advancement in cancer imaging diagnostics.

Investigated diseases

  • Cholangiocarcinoma

    A cancer that develops in the bile ducts, which are tubes that connect the liver and gallbladder to the small intestine. The disease begins in the cells that line the bile ducts, gradually causing the tubes to narrow and malfunction. As the condition progresses, it can affect both the ducts inside and outside the liver. The cancer cells can grow and form tumors that block the bile ducts.

  • Pancreatic Cancer

    A disease that occurs when abnormal cells develop in the pancreas, an organ located behind the stomach. The condition typically starts in the cells that line the ducts of the pancreas, which are responsible for carrying digestive enzymes. The disease can affect both the exocrine and endocrine functions of the pancreas. As it develops, it can interfere with the pancreas's ability to produce digestive enzymes and hormones.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-516486-36-00Estimated enrolment63 patientsSponsorAmsterdam UMC

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