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Evaluating 68Ga-FAPI-46 PET/CT Scanning for Improved Diagnosis in Patients with Pancreatic Cancer or Bile Duct Cancer Eligible for Curative Treatment

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What is this trial about?

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

This clinical trial is investigating the diagnostic value of 68Ga-FAPI-46 PET/CT scans in patients with pancreatic adenocarcinoma (a type of pancreatic cancer) and cholangiocarcinoma (bile duct cancer) who may be eligible for curative treatment. The study aims to determine whether adding this special imaging technique to standard diagnostic examinations can improve the accuracy of cancer staging, which is the process of determining how far a cancer has spread in the body.

The PET/CT (Positron Emission Tomography/Computed Tomography) scan being studied uses a substance called 68Ga-FAPI-46, which is a radioactive tracer that attaches to certain proteins found in cancer cells. This allows doctors to potentially see cancer that might be missed by conventional imaging techniques. The purpose of the study is to evaluate whether this imaging method can detect additional cancer spread that would change the treatment approach for patients.

Participants in this study will undergo standard diagnostic tests as well as the additional 68Ga-FAPI-46 PET/CT scan. Researchers will compare the results of standard imaging with the results after adding the new PET/CT technique to see if it leads to changes in the cancer's staging or treatment plan. The study will separately analyze results for pancreatic cancer and bile duct cancer patients.

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 Staging

    You will undergo standard initial staging examinations for your pancreatic adenocarcinoma or cholangiocarcinoma (bile duct cancer). These are the usual tests that help determine the extent of the cancer.

    The standard tests typically include imaging studies to determine if your cancer is potentially curable and non-metastatic (has not spread to distant parts of the body).

  2. Step 2

    68Ga-FAPI-46 PET/CT Scan

    You will receive an additional imaging test called a 68Ga-FAPI-46 PET/CT scan. This is a special type of scan that uses a radioactive substance to help better identify cancer cells.

    For this scan, you will receive an injection of a substance called gallium-68 FAPI-46. The dose will be between 0.74 and 1.85 GBq (gigabecquerels, a measure of radioactivity).

    After the injection, you will undergo a combined PET/CT scan where a machine takes detailed pictures of your body to look for cancer cells that might not be visible on standard imaging tests.

  3. Step 3

    Comparison of Results

    Medical specialists will compare the results from your standard staging tests with the results from the 68Ga-FAPI-46 PET/CT scan.

    They will look for any additional cancer sites that might have been missed by standard tests, particularly checking if the cancer has spread to lymph nodes or distant organs.

    The goal is to determine if the PET/CT scan provides additional information about the extent of your cancer (known as TNM classification) compared to standard tests.

  4. Step 4

    Treatment Planning Review

    Based on the combined results, your medical team will review your treatment plan.

    If the 68Ga-FAPI-46 PET/CT scan reveals additional information about your cancer, your treatment approach might be adjusted. This could include changes to surgical plans, addition or removal of chemotherapy or radiation therapy, or other modifications to your care plan.

  5. Step 5

    Study Completion

    After your treatment plan has been finalized based on all available information, your participation in this particular aspect of the study will be complete.

    The researchers will analyze how the additional 68Ga-FAPI-46 PET/CT scan influenced your diagnosis and treatment planning compared to standard tests alone.

Who can join the trial?

8 criteria

  • Age over 18 years at the time of signing the informed consent form
  • Patient must be affiliated with a social security system
  • Patient must have signed a free and informed consent form (before any research examinations begin)
  • Patient must have one of the following conditions:
    • Newly diagnosed pancreatic adenocarcinoma (confirmed by tissue sample) OR strong suspicion of pancreatic adenocarcinoma based on imaging tests that is:
      • Immediately resectable (can be surgically removed), borderline resectable, or locally advanced
      • Potentially eligible for curative treatment (treatment aimed at curing the disease)
      • Non-metastatic (cancer has not spread to distant parts of the body)
      • OR newly diagnosed cholangiocarcinoma (bile duct cancer, confirmed by tissue sample) OR strong suspicion of cholangiocarcinoma based on imaging that is:
        • Eligible for curative treatment
        • Non-metastatic

Who cannot join the trial?

8 criteria

  • You cannot participate if you are pregnant or breastfeeding.
  • You cannot participate if you are under legal protection (such as having a guardian or conservator).
  • You cannot participate if you have a known allergy to the radioactive tracer (68Ga-FAPI-46) used in the special imaging test.
  • You cannot participate if you are unable to provide informed consent or understand the study requirements.
  • You cannot participate if you have already received treatment for your cancer (like chemotherapy, radiation, or surgery).
  • You cannot participate if your cancer is not considered potentially curable by the medical team.
  • You cannot participate if you cannot undergo the required imaging tests due to physical limitations or medical conditions.
  • You cannot participate if you are participating in another clinical trial that would interfere with this study.
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Investigated drugs

68Ga-FAPI-46 PET/CT is an imaging test that uses a special tracer (68Ga-FAPI-46) that attaches to proteins often found in cancer cells. This helps doctors see cancer more clearly in a PET/CT scan. In this study, it's being used to better identify the extent of pancreatic and bile duct cancers, which could help determine the most appropriate treatment plan.

What is already known about the treatment

68Ga-FAPI-46 – A radioactive diagnostic tracer administered intravenously for PET/CT imaging that specifically binds to fibroblast activation protein (FAP), which is highly expressed in cancer-associated fibroblasts. This novel imaging agent is currently being investigated in clinical trials for improved detection and staging of pancreatic adenocarcinoma and cholangiocarcinoma (bile duct cancer), potentially offering better visualization of tumor extent compared to conventional imaging methods. 68Ga-FAPI-46 works by targeting the tumor microenvironment rather than cancer cells themselves, allowing visualization of desmoplastic reaction (fibrous tissue) commonly surrounding these aggressive cancers. It belongs to the class of radiopharmaceuticals used for molecular imaging in nuclear medicine.

Investigated diseases

  • Cholangiocarcinoma

    is a cancer that forms in the bile ducts, which are thin tubes that carry bile from the liver to the small intestine. It starts in the cells lining the bile ducts and can develop in different parts of the bile duct system—inside the liver (intrahepatic), just outside the liver (perihilar), or closer to the small intestine (distal). The disease progresses as cancer cells multiply and grow, eventually forming a tumor that can block bile flow. As it advances, cholangiocarcinoma can spread to nearby lymph nodes and may metastasize to distant organs such as the lungs or peritoneum. The disease typically develops slowly over time, often without noticeable symptoms in its early stages.

  • Pancreatic adenocarcinoma

    is a cancer that originates in the exocrine cells of the pancreas, which produce enzymes to aid digestion. It most commonly develops in the head of the pancreas, though it can occur in any part of the organ. The disease begins when cells in the pancreatic ducts undergo genetic changes that cause them to grow uncontrollably and form a tumor. As it progresses, pancreatic adenocarcinoma can invade surrounding tissues including blood vessels, nerves, and adjacent organs. The cancer often spreads to nearby lymph nodes and can metastasize to distant sites such as the liver, lungs, and peritoneum. Pancreatic adenocarcinoma is characterized by its ability to spread silently before causing significant symptoms.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517270-23-00Protocol codeCHUBX 2022/39Estimated enrolment120 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

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