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Study on 68Ga-FAPI-46 PET Imaging for Patients with Gastrointestinal Cancers

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 various types of gastrointestinal cancers, which include liver cancer, bile duct cancer, stomach cancer, pancreatic cancer, colon cancer, and esophageal cancer. The study will use a special imaging technique called 68Ga-FAPI-46 PET to help visualize these cancers. This technique involves a solution that is injected into the body and helps to create detailed images of the cancerous areas.

The purpose of the study is to evaluate how well the 68Ga-FAPI-46 PET imaging works in detecting gastrointestinal cancers. Participants in the study will undergo this imaging process, which is designed to provide clear pictures of the cancerous regions. The study will compare the results of this new imaging method with previous standard imaging techniques to see if it offers better detection of cancer locations.

Throughout the study, the safety of the 68Ga-FAPI-46 PET imaging will be monitored, including any side effects that may occur. The study will also assess how the imaging results might influence treatment decisions made by doctors. This research aims to improve the understanding of how effective this imaging method is in identifying and managing gastrointestinal cancers.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, type of cancer, and health status.

    A negative pregnancy test is required for women who can become pregnant, conducted within 24 hours before the administration of the radiopharmaceutical.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to document the current stage of the disease and any previous treatments.

    This includes a review of medical history and a physical examination.

  3. Step 3

    Radiopharmaceutical administration

    The radiopharmaceutical 68Ga-FAPI-46 is administered as a solution for infusion through an injection.

    This step is crucial for the imaging process that follows.

  4. Step 4

    Imaging procedure

    A positron emission tomography (PET) scan is performed to capture images of the gastrointestinal cancers.

    The scan helps in evaluating the presence and extent of cancerous lesions.

  5. Step 5

    Follow-up and analysis

    The results from the PET scan are analyzed to determine the effectiveness of the imaging in detecting cancer.

    The findings are compared with previous standard imaging techniques and confirmed through biopsy or histopathology.

  6. Step 6

    Monitoring and reporting

    Participants are monitored for any adverse events or changes in health status.

    Regular follow-ups are conducted to assess the impact of the imaging on treatment decisions and disease management.

Who can join the trial?

7 criteria

  • The patient must have a confirmed or suspected case of **gastrointestinal cancer**. This includes cancers of the liver (**hepatocellular carcinoma**), bile ducts (**cholangiocarcinoma**), stomach (**gastric cancer**), pancreas, colon or rectum (**colorectal cancer**), and esophagus.
  • The patient should be at the initial stage of diagnosis or undergoing a re-evaluation of their disease.
  • The patient must have at least one tumor that can be detected and is larger than 1 centimeter in diameter.
  • The patient should have had or plan to have surgery or a biopsy of the tumor within 8 weeks before or after joining the study. They must agree to use the tumor sample for a special test called **immunohistochemical analysis** to check for a protein called **FAP**.
  • The patient must be 18 years of age or older.
  • The patient should have a performance status of 2 or less on the **ECOG scale**, which is a way to measure how well a patient can perform daily activities.
  • Women who can become pregnant must have had a recent menstrual period and a negative pregnancy test within 24 hours before receiving the study's special imaging test.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with **gastrointestinal cancers**. This includes cancers of the stomach, liver, pancreas, colon, and esophagus.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

68Ga-FAPI-46 is a special imaging agent used in a type of scan called positron emission tomography (PET). This agent helps doctors see certain types of gastrointestinal cancers more clearly. It works by attaching to specific parts of cancer cells, making them visible on the PET scan. This can help doctors understand the cancer better and plan the best treatment for the patient.

What is already known about the treatment

68Ga-FAPI-46 – This medication is administered through an injection and is used in a PET scan, a type of imaging test. It is currently being studied in clinical trials for its effectiveness in detecting various gastrointestinal cancers, such as liver, bile duct, stomach, pancreatic, colorectal, and esophageal cancers. The main purpose of 68Ga-FAPI-46 is to help visualize cancerous tissues by binding to a specific protein that is often found in high amounts in these tumors. It belongs to the class of radiopharmaceuticals, which are drugs that contain radioactive substances used for diagnosis or treatment.

Investigated diseases

  • Hepatocellular Carcinoma

    This is a type of liver cancer that begins in the main type of liver cell, known as hepatocytes. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis. The disease may start as a single tumor or multiple small cancer nodules throughout the liver. As it progresses, it can invade nearby blood vessels and spread to other parts of the body.

  • Cholangiocarcinoma

    This cancer arises from the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. It can occur anywhere along the bile ducts and is often classified based on its location. The disease may cause blockages in the bile ducts, leading to jaundice and other symptoms. Over time, it can spread to nearby organs and tissues.

  • Gastric Cancer

    Also known as stomach cancer, this disease begins in the cells lining the stomach. It can develop slowly over many years and may initially cause symptoms like indigestion or stomach discomfort. As it advances, the cancer can invade deeper layers of the stomach wall and spread to nearby lymph nodes and other organs.

  • Pancreatic Cancer

    This cancer starts in the tissues of the pancreas, an organ that lies behind the lower part of the stomach. It often begins in the cells that line the ducts of the pancreas. The disease may grow and spread quickly, affecting nearby organs such as the liver and intestines. Symptoms often appear only after the cancer is advanced.

  • Colorectal Cancer

    This type of cancer affects the colon or rectum, which are parts of the large intestine. It typically starts as small, noncancerous clumps of cells called polyps that can develop into cancer over time. As the disease progresses, it can invade the wall of the colon or rectum and spread to nearby lymph nodes and other organs.

  • Oesophageal Cancer

    This cancer occurs in the esophagus, the long tube that carries food from the throat to the stomach. It usually begins in the cells lining the inside of the esophagus. The disease can cause difficulty swallowing and may spread to nearby tissues and lymph nodes as it advances.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-506030-70-00Protocol codeFAPI-PET-GIEstimated enrolment150 patientsSponsorUniversitaetsklinikum Essen AöR

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