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Study of 18F-FAPI-74 PET/CT Imaging to Detect Cancer Spread in Patients with Non-Small Cell Lung Cancer

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What is this trial about?

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

This study is looking at non-small cell lung cancer, which is a type of cancer that affects the lungs. The study will use a substance called [18F]FAPI-74, which is given as an injection into a vein. This substance is used together with a special scanning method called PET/CT imaging, which creates detailed pictures of the inside of the body. The substance helps doctors see areas where cancer cells might be present because it attaches to a specific protein that is often found in and around cancer tissue.

The purpose of this study is to see if this imaging method can help doctors find out whether the cancer has spread to lymph nodes, which are small bean-shaped organs that are part of the body's defense system, or to other parts of the body that are far from where the cancer started. The study will look at patients who have not received any treatment yet, as well as patients who have already had surgery, radiation therapy, or other treatments for their lung cancer and might have cancer that has come back.

During the study, patients will receive a single injection of the substance and then have imaging scans taken to see how well the substance shows areas of cancer in the body. Doctors will measure how much of the substance collects in different areas and will compare the scan results with tissue samples taken from suspected cancer areas to confirm whether cancer is present. The study aims to determine if this imaging approach can be useful in understanding where the cancer is located and whether it has spread.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial imaging procedure
You will receive an injection of [18F]FAPI-74, which is a radioactive solution used for imaging. This substance helps to visualize specific proteins in your body that may be associated with lung cancer.
The injection will be administered intravenously, which means it will be given directly into a vein.
After receiving the injection, you will undergo a PET/CT scan. This is a type of imaging test that combines two scanning technologies to create detailed pictures of the inside of your body.
Step 2
Image analysis
The images obtained from the scan will be analyzed to measure how much of the injected substance has accumulated in different areas. This is measured using values called SUVmax, SUVmean, and SUVpeak.
These measurements will help assess the primary tumor, any lymph node involvement, or potential spread of cancer to other parts of the body.
If you have previously received treatment for lung cancer, the scan will also be used to check for any cancer recurrence.
Step 3
Tissue confirmation
If the imaging identifies any suspicious areas, tissue samples may be collected from these locations to confirm the presence of cancer cells.
This step ensures that the findings from the imaging are accurate and helps guide further treatment decisions.

Who can join the trial?

6 criteria

You must have a confirmed diagnosis of non-small cell lung cancer, which is a type of lung cancer, specifically either adenocarcinoma or squamous cell carcinoma, which are the two main types of this cancer confirmed by examining tissue samples under a microscope
For Study 1: You must not have received any previous treatment for your lung cancer, meaning no surgery, no radiation therapy, and no medical treatment such as chemotherapy
For Study 2: You must have already been treated for your lung cancer with one of the following: lobectomy, which is surgery to remove part of the lung, stereotactical radiotherapy, which is a precise type of radiation treatment, or chemoradiotherapy, which is a combination of chemotherapy and radiation therapy
For Study 1: Your cancer must be classified as Stage I, II, or III, which means the cancer is present in the lung and may have spread to nearby lymph nodes but has not spread to distant parts of the body
You must be older than 18 years of age
Both men and women can participate in this study

Who cannot join the trial?

4 criteria

The study information does not list specific reasons why patients cannot participate in this clinical trial
If you are interested in participating, the research team will need to review your individual medical situation to determine if you are eligible
General factors that often prevent participation in cancer studies may include pregnancy, which means carrying an unborn baby, breastfeeding, which means nursing a baby, certain other medical conditions, or taking specific medications
The imaging test uses a small amount of radioactive material, which is a substance that gives off energy that can be detected by special cameras, so this may affect who can safely participate

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Turku University Hospital
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Turku, Finland

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Investigated drugs

18F-FAPI-74 is a radioactive tracer used during PET/CT scans to help doctors see and evaluate cancer in the body. This imaging agent attaches to a specific protein called fibroblast activation protein that is often found in higher amounts in cancer tissue. When used with a PET/CT scanner, it helps create detailed pictures that show where cancer may have spread to lymph nodes or other parts of the body in patients with non-small cell lung cancer.

[Al[18F]F]Fapi-74

What is already known about the treatment

18F-FAPI-74 – This is a radioactive tracer administered intravenously and used during PET/CT imaging scans to detect cancer cells in the body. It is currently being studied in clinical trials to evaluate its effectiveness in identifying the spread of non-small cell lung cancer to lymph nodes and distant organs. The medication works by attaching to a protein called fibroblast activation protein, which is commonly found in higher amounts around cancer cells, making tumors visible on imaging scans. This substance belongs to the class of diagnostic radiopharmaceuticals used for cancer detection and staging.

Investigated diseases

Non-Small Cell Lung Cancer – Non-small cell lung cancer is a type of cancer that begins in the lungs and affects the cells lining the airways. It is the most common form of lung cancer, accounting for approximately 85% of all lung cancer cases. The disease develops when abnormal cells in the lung tissue grow uncontrollably and form tumors. As the cancer progresses, it can spread to nearby lymph nodes in the chest. In more advanced stages, the cancer may spread to distant parts of the body through a process called metastasis. The cancer can also recur after initial treatment, appearing either in the same location or in other areas of the body.