Not yet recruiting

Diagnostic Accuracy of [18F]FAPI-74 PET/CT for Detecting Metastasis and Assessing Treatment Response in Gastric Cancer Patients

Investigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

The study focuses on Gastric cancer, a type of stomach cancer that can grow locally and spread to other parts of the body. It evaluates the diagnostic agent [18F]FAPI-74, which is given by a small injection and then visualized using a special imaging method called PET/CT. PET/CT is a scan that combines two types of pictures – one that shows how cells use sugar (PET) and another that shows the body’s shape (CT) – to create detailed images. Metastasis means cancer cells have moved away from the original spot to other organs, and lymph nodes are small glands that help fight infection and can be places where cancer spreads. The purpose of the study is to determine how accurately this test can locate the primary tumor, involved lymph nodes, and distant metastasis, as well as to see if it can show the response to treatment given before surgery.

Participants will receive a single dose of the tracer, then undergo the scan a short time later. The images are compared with the findings from tissue analysis after surgery or with routine follow‑up scans to confirm whether the cancer has spread. The study follows each participant from the initial scan through surgery and a one‑year follow‑up period to collect the needed information.

The research process

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

Step 1
Enrollment and consent
after joining the study, the patient signs the informed consent form and provides basic personal and health information.
baseline data such as medical history and current medications are recorded.
Step 2
Baseline assessments
the patient undergoes initial examinations that may include blood tests and routine imaging to document the status of gastric cancer before any study procedures.
Step 3
Tracer preparation and injection
on the day of the first imaging session, the patient receives an injection of the diagnostic tracer [18f]fapi-74.
the injection contains a dose of 300 mbq (megabecquerel) of the tracer, delivered as a solution for injection.
Step 4
Distribution waiting period
after the injection, the patient waits a short period to allow the tracer to circulate and bind to target tissue.
Step 5
Pet/ct imaging
the patient undergoes a pet/ct scan of the abdomen and pelvis to visualize the primary tumor, regional lymph nodes, and possible distant metastases.
the images are used to assess the accuracy of the tracer in detecting cancer sites.
Step 6
Neoadjuvant therapy response assessment (if applicable)
if the patient receives neoadjuvant therapy (treatment before surgery), a second tracer injection and pet/ct scan are performed after the therapy course.
this repeat imaging evaluates changes in the tumor and helps determine the response to therapy.
Step 7
Surgical and histopathology correlation
following surgery, tissue samples are examined by pathology to confirm the presence or absence of cancer in the areas identified by the pet/ct scan.
the findings are compared with the imaging results to assess diagnostic accuracy.
Step 8
Long‑term follow‑up
the patient is monitored for up to one year after the study procedures.
routine clinical follow‑up imaging, such as ct scans, or histopathology results from any subsequent procedures are used to compare with the initial pet/ct findings.

Who can join the trial?

4 criteria

You have a suspected first‑time (primary) or returning (recurrent) gastric cancer (stomach cancer).
You are between 18 and 85 years old, male or female.
Your overall health lets you carry out daily activities at a level called a WHO performance score of 0‑2 (0 = fully active, 1‑2 = able to work but with some limitations).
You are able to read, understand, and sign a written informed consent form, showing that you agree to follow the study’s requirements.

Who cannot join the trial?

3 criteria

People who are considered vulnerable—such as individuals who are disabled, children, pregnant or breastfeeding women, or prisoners—cannot take part in the study.
If you are unable to understand the purpose of the study, you cannot join.
If you have a medical condition that makes a whole-body PET/CT imaging scan (a scan that looks at the entire body using special imaging technology) unsafe or impossible, you cannot participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

[18F]FAPI-74 is a special imaging agent that is injected into the body before a PET/CT scan. It contains a tiny amount of a radioactive substance that helps the scanner see cancer cells more clearly. In this study, the agent is used to find lymph nodes or other places where stomach cancer may have spread, and to check how well the cancer is responding to treatment before surgery. By highlighting the cancer tissue, doctors can get a more accurate picture of the disease without needing an invasive procedure.

[Al[18F]F]Fapi-74

What is already known about the treatment

[18F]FAPI-74 - This drug is given as an injection of a sterile solution that contains the radioactive tracer [18F]FAPI-74. It is currently an investigational radiopharmaceutical used mainly in research and early clinical studies, and is not yet approved for routine medical use. The tracer helps doctors see gastric cancer and its spread by attaching to a protein called fibroblast activation protein that is often present on tumor cells, allowing PET/CT scans to highlight the disease. It belongs to the class of PET imaging agents that use fluorine‑18 labeled molecules to visualize tumors.

Investigated diseases

Gastric cancer - Gastric cancer is a type of cancer that starts in the lining of the stomach. It begins when cells in the stomach wall grow uncontrollably and form a tumor. The tumor may stay limited to the inner layers at first, but it can spread outward through the stomach wall. As it grows, it can reach nearby lymph nodes and other organs. The disease may also spread to distant parts of the body through the bloodstream. Over time the size and spread of the tumor can change the shape and function of the stomach.