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AuthorisedTherapeutic exploratory (Phase II)Interventional

"Contribution of 68Ga-FAPI-46 PET-CT in the initial staging of gastric cancers eligible for curative treatment" "FAPGASTRO"

This research study is for people in the UK recently diagnosed with stomach cancer who could have surgery to cure it. Doctors are investigating whether a particular type of scan, called 68Ga-FAPI-46 PET-CT, can improve how we figure out the cancer's stage when it's first found. Staging helps doctors decide the best treatment plan. By adding this new scan to the usual checks, the study aims to see if it gives doctors clearer information about how much the cancer has spread. This could help them choose the most suitable treatments, such as surgery, chemotherapy, or radiotherapy, and hopefully lead to better outcomes for patients. It's a Phase II study, meaning it's exploring how well this new scan works.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Centre Hospitalier Universitaire De Bordeaux
Enrolment target
40
Start
30 Apr 2026

What is this study about?

This study, called "FAPGASTRO," is looking into a new way to get a clearer picture of stomach cancer in its early stages. When someone is diagnosed with stomach cancer, doctors need to know how far it has spread – this is called "staging." Knowing the correct stage is really important because it helps doctors choose the best treatment plan for each person, whether that's surgery, chemotherapy, radiotherapy, or a combination.

Currently, doctors use standard scans and tests to stage stomach cancer. This study is adding a special type of scan called 68Ga-FAPI-46 PET-CT into the mix. Researchers want to see if this new scan, when used alongside the usual tests, gives doctors more accurate or helpful information about the cancer's spread. For example, it might help them see hidden spots of cancer that weren't obvious before, or confirm that cancer hasn't spread as much as initially thought.

The main goal is to find out if using this new scan changes the cancer stage doctors would have decided on using only the standard tests. If it does, and this change helps doctors pick a more suitable treatment plan for patients, then this new scan could become a valuable tool in the future. The study will also compare how well this new scan finds cancer spots compared to current methods and check if different doctors interpret the scan results in the same way.

Key takeaways

  • This study evaluates a new scan (68Ga-FAPI-46 PET-CT) for stomach cancer.
  • The goal is to improve how doctors 'stage' the cancer, which means understanding how much it has spread.
  • Better staging can lead to more tailored and effective treatment plans.
  • It's for adults with stomach cancer that doctors think could be cured.
  • The new scan would be used alongside standard tests, not instead of them.

Who may be eligible?

This study is looking for adult men and women, aged 18 and over, who have recently been diagnosed with stomach cancer. To be considered for this study, your doctors must believe that your cancer could potentially be cured with treatment, such as surgery.

You would need to be well enough to take part in the study and potentially undergo the planned treatments. The research team will carefully check your medical history and current health to make sure this study is a safe and suitable option for you.

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.

  1. Are you 18 years old or older?
  2. Have you recently been diagnosed with stomach cancer?
  3. Do your doctors think your cancer might be curable?
  4. Are you able to undergo standard medical scans and tests?
  5. Are you in general good health apart from your cancer diagnosis?
Answer every question to see your result.

What does participation involve?

We don’t have all the details about what participating in this specific study involves. However, based on similar studies that use scans, if you choose to take part, you would likely have a special type of scan called a 68Ga-FAPI-46 PET-CT. This would be in addition to the standard scans and checks your doctors would already be doing to understand your cancer.

Before the scan, you would be given a small amount of a special substance called 68Ga-FAPI-46, which helps the scan highlight cancer cells. This is usually given through a vein. You would then lie still inside the scanner for a period of time while the pictures are taken. The research team will explain all the steps to you clearly if you are considering joining. The total duration of your involvement could depend on your treatment plan and follow-up.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the additional scan might give your doctors a more detailed picture of your cancer, which could help them decide on the most suitable treatment plan for you. On the other hand, there might be slight risks associated with the scan itself, such as a very small exposure to radiation from the substances used, similar to regular medical scans. Some people might also have a mild reaction to the substance given. You are always free to ask questions and 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.
  • Unverified
    France

Common questions

What is 68Ga-FAPI-46 PET-CT?

It's a special type of scan that uses a small amount of a 'tracer' substance to help doctors see areas of cancer more clearly than standard scans might.

Who can take part in this study?

Adults aged 18 or over with stomach cancer that doctors believe can potentially be cured by treatment.

Will this scan replace my usual tests?

No, this scan is given *in addition* to your usual tests to see if it gives doctors more useful information.

What does 'staging' mean?

Staging means figuring out how much cancer is in your body and if it has spread. This helps doctors plan the best treatment.

Is the substance given for the scan safe?

Yes, it contains a very small amount of radiation, similar to other medical scans, and is carefully controlled by medical professionals.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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