AuthorisedTherapeutic exploratory (Phase II)Interventional

Improved baseline staging with 68Ga-FAPI-46 PET in non-small cell lung cancer – a pilot study

This research study is about non-small cell lung cancer. Doctors want to see if a newer type of scan, called 68Ga-FAPI-46 PET, is better or different at finding how far the cancer has spread compared to the scans currently used (18F-FDG PET and a brain MRI). The main aim is to understand how well the new scan works so they can plan bigger studies in the future. They will be looking at how many cancer spots each scan finds and where they are located. This could help doctors get a clearer picture of the cancer at the beginning, which might help decide the best treatment plan.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Academisch Ziekenhuis Maastricht

Enrolment target

Start

03 Feb 2026

Non-small cell lung cancer

What is this study about?

This study is investigating a new scanning method for people diagnosed with non-small cell lung cancer. When someone is diagnosed with cancer, doctors need to understand if and where the cancer has spread in the body. This is called 'staging.' Currently, a common way to do this involves a scan called an 18F-FDG PET in combination with a brain MRI scan.

This new study is testing a different type of scan called 68Ga-FAPI-46 PET. The researchers want to compare the new scan with the standard scans to see if it can find cancer spots that the usual scans might miss, or vice versa. By doing this, they hope to gather important information that will help them design future studies to see if this new scan could offer a more complete picture of the cancer.

The main goal is to understand how well the 68Ga-FAPI-46 PET scan works in finding cancer spread. This information is crucial for figuring out if this new scan could help doctors make more accurate decisions about a patient's cancer stage and, in the long run, potentially lead to more tailored and effective treatment plans.

Key takeaways

This study uses a new scan (68Ga-FAPI-46 PET) for non-small cell lung cancer.
It compares the new scan to standard scans (18F-FDG PET and brain MRI) to find cancer spread.
The aim is to gather information for future, larger studies.
Participation involves receiving the new scan and having its results compared to standard care.
It could help improve how doctors stage lung cancer in the future.

Who may be eligible?

To be able to take part in this study, you must be at least 18 years old. There is no upper age limit.

This study is open to both men and women. The specific medical requirements are not fully detailed here, but participants will have been diagnosed with non-small cell lung cancer.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have a diagnosis of non-small cell lung cancer?
Are you comfortable with having different types of body scans?
Are you willing to participate in a research study comparing diagnostic methods?

Answer every question to see your result.

What does participation involve?

This study is in its early stages (Phase II), meaning it's still exploring how a new scan works. If you decide to take part, you would receive the investigational 68Ga-FAPI-46 scan. This involves being given a very small, safe amount of a special substance (called 68Ga-FAPI-46, or "Steripet") that helps the scan show up areas of interest in your body. It is given as an injection, similar to a blood test.

During the study, your doctors will compare the results of this new scan with the results of your standard scans (like the 18F-FDG PET and brain MRI). You will likely have several appointments for these scans and follow-ups. The total duration of your involvement isn't specified, but it's designed to gather information that will help plan future, larger studies.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit of this study is that it might provide doctors and researchers with more information about how different scans work in detecting your type of cancer, which could help improve future care for people with non-small cell lung cancer. However, this study is primarily to gather data rather than directly benefit you. The potential risks associated with the scans include exposure to low levels of radiation, similar to other medical imaging tests. You will be fully informed of all known risks before deciding to take part, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. This study focuses on people diagnosed with this specific kind of cancer.

What is a PET scan?

A PET scan is a type of imaging test that helps doctors see how your organs and tissues are working. It can help find cancer cells in the body.

Why are they testing a new scan?

Doctors are always looking for better ways to find out how far cancer has spread. This study explores if a new scan can give a clearer picture than current methods.

Will I get a special medicine in this study?

You will receive a small amount of a special substance called 68Ga-FAPI-46, which is injected to help the new scan work. It's not a treatment, but helps with imaging.

What does 'Phase II' mean?

Phase II means it's an early stage of clinical research. It's designed to understand if a new test or treatment is safe and how well it works, before larger studies begin.