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A study comparing 68Ga-FAPI-46 PET scan with standard 18F-FDG PET scan and brain MRI for staging in patients with newly diagnosed 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 involves patients with non-small cell lung cancer, which is a type of lung cancer. The study will use two different imaging substances to take pictures of the inside of the body. One substance is called 68Ga-FAPI-46, which is the main substance being tested in this study. The other substance is fludeoxyglucose (18F), which is already commonly used in regular medical care. Both substances are given through a vein and help doctors see where cancer may be present in the body using special scanning machines. Patients in this study will also have a brain scan called an MRI, which uses magnetic fields to create detailed pictures of the brain.

The purpose of this study is to gather information that will help plan a larger study in the future. Researchers want to compare how well the new imaging substance 68Ga-FAPI-46 works compared to the standard method that uses fludeoxyglucose (18F) and brain MRI for finding cancer that has spread to other parts of the body in patients who have been newly diagnosed with non-small cell lung cancer. The study will look at how many cancer spots are found with each method and where these spots are located in the body.

During the study, patients will receive scans with both imaging substances. They will first have or will have already had a scan with fludeoxyglucose (18F) as part of their regular care. Within three weeks, they will also receive a scan using 68Ga-FAPI-46. If a brain MRI has not already been done, patients will also undergo this scan. Doctors will then compare the results from both types of scans to see if the new substance finds cancer spots that the standard method might miss, or if the standard method finds spots that the new substance does not detect.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial imaging scan
Your participation in the trial begins after your lung cancer diagnosis has been confirmed through a biopsy. At this stage, you will either need to undergo a standard 18F-FDG PET/CT scan for diagnostic evaluation, or you may have already completed this scan.
The 18F-FDG PET/CT scan is an imaging procedure that uses a radioactive tracer called fludeoxyglucose combined with a computed tomography scan. This tracer is injected into your vein and helps to identify areas of increased metabolic activity, which may indicate cancer. The scan provides detailed images of your body to assess the extent of the disease.
If you have not yet had this scan, it will be performed as part of your standard diagnostic process.
Step 2
Brain imaging assessment
You will undergo a brain MRI scan if this has not already been performed or scheduled as part of your regular care.
The MRI scan uses magnetic fields and radio waves to create detailed images of your brain. This scan helps to detect whether the cancer has spread to the brain.
This imaging procedure is part of the current standard approach to evaluate your condition.
Step 3
Additional imaging with experimental tracer
Within three weeks after your 18F-FDG PET/CT scan, you will undergo an additional imaging scan called a 68Ga-FAPI-46 PET scan with a low-dose CT.
For this scan, you will receive an injection of a radioactive tracer called 68Ga-FAPI-46. This substance is administered as an intravenous bolus, which means it is injected directly into your vein as a single dose.
The 68Ga-FAPI-46 tracer works differently from the standard tracer. It targets specific proteins associated with cancer tissue, which may help to identify cancer spread in different ways than the standard scan.
The low-dose CT component provides anatomical images with reduced radiation exposure compared to a standard CT scan.
This additional scan is the investigational part of the trial and is performed to compare its effectiveness with the standard imaging methods.
Step 4
Comparison of imaging results
After all imaging scans are completed, the results from the 68Ga-FAPI-46 PET scan will be compared with the results from your 18F-FDG PET/CT scan and brain MRI.
The comparison will assess whether the experimental scan detects cancer spread that was not visible on the standard scans, or whether the standard scans show findings not visible on the experimental scan.
If the 68Ga-FAPI-46 PET scan reveals findings that were not seen on the standard scans, additional clinical investigations may be necessary to clarify these findings.
The information gathered will help determine whether the experimental imaging method could be useful for future patients with lung cancer.

Who can join the trial?

7 criteria

You must have non-small cell lung cancer that has been confirmed by a biopsy, which is a procedure where a small sample of tissue is removed and examined under a microscope to check for cancer cells
You need to either require a special imaging scan called 18F-FDG PET/CT, which is a test that uses a small amount of radioactive sugar to find cancer in the body, or you must have already had this scan done
You must be at least 18 years old
Your ability to perform daily activities must be rated as ECOG score 0-2, which means you are either fully active, able to do light work, or capable of self-care but unable to work
You must be able to have another imaging scan called 68Ga-FAPI-46 PET with low dose CT within three weeks after your first scan
You must be willing and able to have a brain MRI, which is a scan that uses magnets and radio waves to create detailed pictures of your brain, if you have not already had one or do not have one scheduled as part of your regular care
You must be willing to sign and date a written informed consent form, which is a document that explains the study and confirms you agree to participate

Who cannot join the trial?

5 criteria

The study data does not provide specific reasons why patients cannot participate in this clinical trial
If you are considering joining a clinical trial, the research team will review your individual medical situation to determine if you are eligible
General factors that often prevent participation in cancer studies may include other serious medical conditions, previous treatments, or medications that could interfere with the study procedures
Pregnancy or breastfeeding (feeding a baby with breast milk) may also be reasons for exclusion in studies involving imaging procedures
The ability to undergo PET scans (special imaging tests that show how organs and tissues are working) and MRI (magnetic resonance imaging, a test that uses magnets and radio waves to create pictures of the inside of your body) may be required

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Verified sites

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University Hospital Maastricht
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Maastricht, The Netherlands

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Investigated drugs

68Ga-FAPI-46
is an imaging agent used during a PET scan to help doctors see cancer cells more clearly in the body. This medication contains a radioactive substance that attaches to certain proteins found on cancer cells, making them visible on special imaging equipment. It is being tested to see if it can provide better images than standard scanning methods for detecting and staging lung cancer.
18F-FDG
is a radioactive sugar solution used as a standard imaging agent for PET scans. Cancer cells absorb this sugar more quickly than normal cells because they use more energy, which helps doctors locate tumors and see how far cancer has spread in the body. This is the current standard method used for imaging in lung cancer patients.

What is already known about the treatment

68Ga-FAPI-46 – This is an investigational radioactive imaging agent administered intravenously that is currently being studied in clinical trials for its potential use in detecting and staging non-small cell lung cancer. The substance works by attaching to a protein called fibroblast activation protein, which is often found in higher amounts in cancer tissues, allowing doctors to see tumor locations more clearly during PET scans. It belongs to the class of radiopharmaceutical diagnostic agents and is being compared to standard imaging methods to determine if it can provide better information about the extent and spread of lung cancer. This medication is still in the research phase and is not yet approved for routine medical use.

Investigated diseases

Non-small cell lung cancer – Non-small cell lung cancer is a type of cancer that begins in the lungs and is the most common form of lung cancer. The disease occurs when cells in the lung tissue start to grow abnormally and uncontrollably, forming tumors. As the cancer progresses, it can spread beyond the lungs to other parts of the body, including the brain, bones, liver, and adrenal glands through a process called metastasis. The cancer cells can invade nearby tissues and enter the bloodstream or lymphatic system, allowing them to reach distant organs. Symptoms may develop gradually and can include persistent cough, chest pain, shortness of breath, and unexplained weight loss. The disease is classified into different stages based on the size of the tumor and how far it has spread throughout the body.