Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

68Ga-FAPI PET/CT: The Diagnostic Accuracy for Primary Staging and Re-staging after Chemotherapy in Patients with Gastric and Gastro-esophageal Junctional Cancer

This research study is investigating new imaging methods for people diagnosed with cancer of the stomach or where the food pipe joins the stomach. Doctors are comparing two types of advanced scans, called FAPI PET/CT and FDG PET/CT. They want to see which scan is more accurate at finding where the cancer is, how far it has spread, and if it has come back after treatment. This includes checking the main cancer, nearby lymph nodes, and any cancer that has spread to other parts of the body. The study also aims to understand how well these scans show changes in cancer after chemotherapy. By finding better ways to see the cancer, doctors hope to gain a clearer picture of the disease and improve how they plan treatments.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Aalborg University Hospital

Enrolment target

Start

06 Nov 2023

Gastroesophageal junction cancer (GEJ-cancer)Gastric cancer

What is this study about?

Imagine your doctor needs to get a very clear picture of cancer inside your body, especially if it's in your stomach or where your food pipe meets your stomach. They also need to know if the cancer changes after treatment, like chemotherapy. This study is exploring a new way to do this using a special type of scan called 'FAPI PET/CT'. This new scan is being compared with a more common scan called 'FDG PET/CT'.

The main aim is to see how accurate the FAPI PET/CT scan is at finding the cancer, including where it started, if it has spread to nearby glands (lymph nodes), or if it has moved to other parts of the body. Doctors want to know if it's better than the FDG PET/CT scan at giving a clear picture of the cancer, both when it's first diagnosed and after you've had chemotherapy. They will compare the scan results with information from actual tissue samples from surgery, which is considered the most accurate way to understand the cancer.

By comparing these scans, researchers hope to discover if FAPI PET/CT can provide more helpful information. This could lead to doctors being able to better understand the stage of your cancer, track how well treatments are working, and make more informed decisions about the best next steps for your care. Ultimately, the goal is to improve how cancers of the stomach and food pipe are managed.

Key takeaways

New scans are being tested for stomach and food pipe cancer.
The study compares FAPI PET/CT with FDG PET/CT.
It aims to improve how doctors find cancer and check treatment success.
Participation involves special scans and review of medical information.
The goal is better understanding and management of these cancers.

Who may be eligible?

This study is open to both men and women. You must be at least 18 years old to take part; there is no upper age limit.

The research is specifically for people who have been diagnosed with cancer of the stomach (gastric cancer) or cancer in the area where the food pipe joins the stomach (gastro-oesophageal junctional cancer).

There might be other health requirements or specific details about your cancer that doctors will check to make sure the study is right for you. Your doctor will be able to tell you if you meet all the necessary criteria.

Quick self-check

Are you at least 18 years old?
Have you been diagnosed with stomach cancer?
Or cancer where your food pipe joins your stomach?
Are you able to undergo PET/CT scans?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would undergo special scans. This would involve receiving an injection of a very small amount of a 'tracer' substance, either 68Ga-FAPI-46 or Fludeoxyglucose (18F), before the PET/CT scan. These tracers help the doctors see the cancer more clearly on the scans. You would have these scans both when your cancer is first diagnosed and again after you have received chemotherapy.

Doctors will compare the results of these scans with information from any tissue samples that are taken, for example, during surgery. They will also look at your medical records and other tests you have had. The full duration of your participation would depend on your treatment plan and the follow-up scans required.

Potential risks and benefits

Taking part in this study may offer some potential benefits, as the imaging techniques used could give your doctors a more detailed understanding of your cancer, which might help in planning your treatment. However, it's important to remember that this is a research study, and there's no guarantee it will directly benefit you personally. Potential risks include the small amount of radiation exposure from the PET/CT scans, similar to that from other diagnostic imaging. There might also be minor discomfort from the injections. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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Denmark

Common questions

What kind of cancers is this study for?

This study is for people with cancer of the stomach or where the food pipe joins the stomach.

What is a PET/CT scan?

A PET/CT scan is a special imaging test that combines two types of scans to create detailed images of the inside of your body, helping doctors find and understand cancer.

What are FAPI PET/CT and FDG PET/CT?

These are two different types of PET/CT scans. Doctors are comparing them to see which one works better for these specific cancers.

Will I get chemotherapy in this study?

The study aims to see how scans show changes after chemotherapy you would already be having, rather than providing the chemotherapy itself.

Is there radiation involved in the scans?

Yes, PET/CT scans do involve a small amount of radiation, similar to other diagnostic scans.