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Study on [18F]-AlF-FAPI-74 for Staging Advanced Stomach Cancer in Patients Using PET/CT and Laparoscopy

Verified siteInvestigationalNo placebo
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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 focused on studying advanced gastric cancer, which is a type of cancer that affects the stomach. The study will use a special imaging technique called [18F]AlF-FAPI-74 PET/CT. This technique involves a solution for injection that helps doctors see the cancer more clearly in the body. The purpose of the study is to see if this imaging method can help doctors better understand the extent of the cancer without needing to perform more invasive procedures like surgery.

Participants in the study will undergo the [18F]AlF-FAPI-74 PET/CT scan, which is a non-invasive way to look at the whole body and check for cancer spread. This scan might reduce the need for a procedure called laparoscopy, where a small camera is inserted into the abdomen to look at the stomach and surrounding areas. The study aims to find out if the scan can help doctors make better decisions about treatment, such as whether surgery is necessary or if other treatments might be more appropriate.

The study will also look at how the scan affects the overall treatment plan, including any changes in surgery plans or additional tests that might be needed. It will assess the impact on patients' quality of life and any extra burden from undergoing the scan. The goal is to improve the way advanced gastric cancer is staged and treated, potentially leading to fewer unnecessary surgeries and better outcomes for patients.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide written informed consent, confirming your understanding and willingness to participate.

  2. Step 2

    Eligibility confirmation

    Your medical history will be reviewed to confirm eligibility. This includes verifying a diagnosis of advanced gastric cancer and ensuring you meet other criteria such as age and surgical resectability of the tumor.

  3. Step 3

    Preparation for imaging

    You will be prepared for a non-invasive imaging procedure using [18F]-AlF-FAPI-74. This involves an intravenous injection of the solution, which helps in visualizing the cancer during the PET/CT scan.

  4. Step 4

    PET/CT scan

    A PET/CT scan will be conducted to assess the spread of the cancer. This imaging helps in determining the extent of the disease and planning further treatment steps.

  5. Step 5

    Multidisciplinary team meeting

    The results from the PET/CT scan will be discussed in a multidisciplinary team meeting. This team will evaluate the findings to decide on the best course of action, which may include changes in treatment plans.

  6. Step 6

    Follow-up and additional procedures

    Based on the scan results, additional procedures such as biopsies or further imaging may be recommended. These steps are taken to gather more information about the cancer.

  7. Step 7

    Questionnaires and feedback

    You will be asked to complete questionnaires about your experience and quality of life. These include the EORTC-QLQ-C30 and EQ-5D-5L, which help in understanding the impact of the trial on your well-being.

  8. Step 8

    Ongoing monitoring

    Throughout the trial, your health will be monitored for any side effects or changes in your condition. This ensures your safety and helps in evaluating the effectiveness of the imaging procedure.

Who can join the trial?

6 criteria

  • Must have a histologically proven adenocarcinoma of the stomach or the esophagogastric junction (Siewert type III). This means that a tissue sample from the stomach or the area where the esophagus meets the stomach has been examined under a microscope and confirmed to be a specific type of cancer.
  • Must be 18 years or older.
  • Must have a surgically resectable, advanced tumor. This means the tumor can be removed by surgery and is at an advanced stage, but has not spread to other parts of the body. This is determined by a gastroscopy (a procedure where a camera is used to look inside the stomach) and a special type of CT scan of the chest and abdomen.
  • There must be an intention to perform a gastrectomy, which is a surgery to remove part or all of the stomach. This decision is made by a team of doctors and the patient together.
  • Must have given written informed consent. This means the patient has been informed about the study and agrees to participate by signing a consent form.
  • If the patient has recently participated in another study involving a new medicine, they can only join if the study team believes it will not interfere with this study. This is based on how the medicines work or the time since the last study.

Who cannot join the trial?

8 criteria

  • Patients with any other type of cancer besides advanced gastric cancer cannot participate.
  • Patients who have had a different type of cancer in the past 5 years are not eligible.
  • Patients who are pregnant or breastfeeding cannot join the study.
  • Patients with severe heart problems are excluded.
  • Patients with severe kidney or liver disease cannot participate.
  • Patients who have had a major surgery in the last 4 weeks are not eligible.
  • Patients who are currently participating in another clinical trial are excluded.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate are not eligible.
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Investigated drugs

[18F]AlF-FAPI-74 is a special type of imaging agent used in PET/CT scans. It helps doctors see detailed pictures of the inside of your body, especially to check for cancer. In this study, it is used to look at the whole body to find out how far advanced gastric cancer has spread. This imaging method is non-invasive, meaning it doesn't require surgery or cutting into the body, and it helps doctors decide if further procedures, like surgery, are necessary.

What is already known about the treatment

[18F]AlF-FAPI-74 – This medication is administered through an injection and is used in a PET/CT scan, which is a type of imaging test. It is currently being studied in clinical trials to see how well it can help doctors understand the spread of advanced gastric cancer without needing more invasive procedures like surgery. The main use of this medication is to help in the staging of advanced gastric cancer, which means determining how far the cancer has spread in the body. At the molecular level, it works by targeting a specific protein that is often found in cancer cells, allowing doctors to see these cells more clearly on the scan. It falls under the category of diagnostic radiopharmaceuticals, which are substances used in medical imaging to help diagnose diseases.

Investigated diseases

Advanced gastric cancer – Advanced gastric cancer is a condition where cancer cells form in the lining of the stomach and have spread beyond the stomach to other parts of the body. It typically begins in the mucosa, the innermost layer of the stomach, and can invade deeper layers as it progresses. The disease may spread to nearby lymph nodes and organs, such as the liver, pancreas, and esophagus. As the cancer advances, it can cause symptoms like difficulty swallowing, weight loss, and abdominal pain. The progression of the disease can lead to complications such as bleeding, obstruction, and perforation of the stomach. Advanced stages often involve metastasis, where cancer cells travel through the bloodstream or lymphatic system to distant organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-513255-32-00Protocol code134826Estimated enrolment250 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

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