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68Ga-FAPI-46 PET-CT for Initial Staging of Gastric Cancer in Patients Eligible for Curative Treatment

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 is being done in gastric cancer, which is cancer that starts in the stomach. It uses 68Ga-FAPI-46, a small radioactive substance given by intravenous injection so it can be seen on a PET-CT scan, a type of imaging test that shows where cancer may be in the body. The purpose of the study is to see whether this scan adds useful information during the first check-up of the cancer before treatment.

The study is for people with stomach cancer that may still be treated with the goal of cure. After the standard tests already used for staging, the participant receives the 68Ga-FAPI-46 injection and then has a PET-CT scan. The doctors then compare the new scan with the usual test results to see whether the understanding of how far the cancer has spread changes in a helpful way. This includes checking the TNM classification, which is a common way to describe the size of the tumor, whether nearby lymph nodes are involved, and whether the cancer has spread to other parts of the body.

The study also looks at whether the scan changes the planned treatment, such as surgery, chemotherapy, or radiotherapy. It is focused on how well the scan can help with the first staging of the disease, including the usual surgical look inside the abdomen when that is part of care. The study uses several forms of the same product for making the radioactive substance, including GalliaPharm and Galliad, but the imaging substance used in the scan is 68Ga-FAPI-46.

The research process

"{\n \"\": [\n {\n \"step\": \"start of the study day\",\n \"step_number\": \"1\",\n \"details\": [\n \"After you join the study, you take part in the initial staging phase for gastric cancer, which means the doctors assess how far the cancer has spread.\",\n \"This assessment includes the usual reference examinations and laparoscopy. Laparoscopy is a type of keyhole surgery used to look inside the abdomen through a small opening.\"\n ]\n },\n {\n \"step\": \"pet-ct with 68ga-fapi-46\",\n \"step_number\": \"2\",\n \"details\": [\n \"You receive 68Ga-FAPI-46 by intravenous injection, which means it is given into a vein.\",\n \"The dose is 350 MBq (megabecquerels), which is a unit used to measure the amount of radioactive material.\",\n \"After the injection, a pet-ct scan is performed. PET-CT means a scan that combines two types of imaging: pet (a scan that shows how tissues take up the injected substance) and ct (a scan that shows detailed pictures of the inside of the body).\"\n ]\n },\n {\n \"step\": \"comparison with reference staging\",\n \"step_number\": \"3\",\n \"details\": [\n \"The results of the 68Ga-FAPI-46 pet-ct are compared with the reference examinations used for the initial staging.\",\n \"The study looks at whether the scan changes the tnm classification. TNM is a system used to describe the tumor, nearby lymph nodes, and whether the disease has spread to other parts of the body.\",\n \"The study also checks whether the scan changes the N status, which describes lymph nodes, and/or the M status, which describes spread to distant parts of the body.\"\n ]\n },\n {\n \"step\": \"treatment plan review\",\n \"step_number\": \"4\",\n \"details\": [\n \"The scan results are used to assess whether any part of the treatment plan should be added or removed.\",\n \"The treatment options considered in the study include curative surgery, chemotherapy, radiotherapy (treatment using radiation), additional surgery, and palliative treatment such as chemotherapy or other systemic treatment (treatment that acts throughout the body).\"\n ]\n }\n ]\n}"

Who can join the trial?

5 criteria

  • Gastric cancer that is either stage II or higher, or a signet-ring cell adenocarcinoma at any stage. An adenocarcinoma is a cancer that starts in gland-like cells, and signet-ring cell describes a specific cancer cell shape seen under a microscope.
  • The cancer must be potentially treatable with curative treatment, meaning treatment is planned with the goal of removing or controlling the cancer completely.
  • Older than 18 years at the time the consent form is signed.
  • Covered by social security insurance, meaning the person has the required health insurance or public coverage needed to take part in the study.
  • Signed informed consent from both the participant and the investigator. Informed consent means the person agrees to join the study after receiving the needed information, and the study doctor also signs the form.

Who cannot join the trial?

11 criteria

  • The tumor has already spread to distant parts of the body, or there is suspicion of distant metastasis on standard tests. Metastasis means cancer that has spread from the original tumor to another part of the body.
  • The person is deprived of liberty by a legal or administrative decision, meaning they are in detention or custody.
  • Neoadjuvant treatment has already started. Neoadjuvant treatment means treatment given before the main treatment, such as surgery.
  • The person has a history of another active cancer, meaning a different cancer that is still present or being treated.
  • There is a known reason why a PET scan with injection of a radioactive substance cannot be done, such as allergy or sensitivity to the radioactive drug or to one of its ingredients.
  • The woman is pregnant.
  • The woman is breastfeeding.
  • The woman can become pregnant but is not using effective contraception, meaning a reliable method to prevent pregnancy.
  • The person is under a legal protection measure or cannot personally give consent, meaning they cannot legally agree to join the study themselves.
  • The person is in an emergency situation.
  • The person is already within an exclusion period from another research protocol, meaning they are not allowed to join because of rules from another study.
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Investigated drugs

  • 68Ga-FAPI-46

    is a tracer used for a PET-CT scan. It is injected into a vein and then helps the scan show areas in the body where cancer may be present. In this trial, it is added to the usual tests to see if it can improve the first staging of gastric cancer and help doctors better understand how far the cancer has spread.

  • GalliaPharm

    is a radionuclide generator used to produce gallium-68, which is needed to prepare the PET scan tracer. It is part of the imaging process and helps make the diagnostic injection possible before the scan is done.

What is already known about the treatment

  • GalliaPharm (gallium (68Ga) chloride)

    This is given as a radioactive source through intravenous use, and it is used only in medical imaging after being attached to another molecule that carries it to the target tissue. In medicine and the medical literature, gallium-68 chloride is a well-known diagnostic substance used to prepare PET scan tracers, especially in research and specialized imaging centers. Its main use is to help doctors find and stage cancer, because the radioactive gallium can be linked to compounds that gather in diseased tissue; at the molecular level, the gallium-68 isotope emits signals that are detected by the scanner, while the attached carrier determines where it goes in the body. It belongs to the pharmacological group of diagnostic radiopharmaceuticals and radionuclide generator products.

  • 68Ga-FAPI-46

    This is a solution for intravenous injection used for PET-CT imaging, where it is injected into a vein and then scanned to show areas of interest in the body. It is an experimental but increasingly studied imaging agent in the medical literature, especially in cancer imaging, including gastric cancer staging. Its main purpose is to help doctors see tumors and possible spread by binding to fibroblast activation protein, a marker often found around many cancers; at the molecular level, the gallium-68 part provides the signal for PET imaging, while the FAPI-46 part helps it attach to the target. It is classified as a diagnostic radiopharmaceutical and a PET imaging tracer.

Investigated diseases

Gastric cancer - Gastric cancer is a malignant disease that begins in the lining of the stomach. It usually develops slowly, often starting as small abnormal cell changes that can gradually grow deeper into the stomach wall. As it progresses, it may spread to nearby lymph nodes and then to other parts of the body. In this study, the focus is on gastric adenocarcinoma, including signet-ring cell adenocarcinoma, which are common forms of this disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524434-25-00Protocol codeCHUBX 2023/40Estimated enrolment40 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

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