RecruitingNAINTERVENTIONAL

PSMA in Gastroenterologic Tumors (GIPSMA)

This study, called GIPSMA, is investigating a new way to look at different types of stomach and gut cancers, such as liver, bowel, or pancreatic cancer. We are using a special type of scan called an 18F-PSMA PET/CT. This scan looks for a specific marker, called PSMA, that can be found on these cancer cells. The main goals are to see if this PSMA marker is present in tissue samples from patients, if the PSMA scan can find more cancer spots than usual scans, and if finding this marker helps predict how patients will respond to standard treatments. This research could help doctors better diagnose and plan treatment for these cancers in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Wuerzburg University Hospital

Enrolment target

Start

01 Oct 2022

Estimated completion

01 Oct 2026

Gastrointestinal Cancer

What is this study about?

Imagine you have a specific type of mobile phone that can send out a unique signal. In this study, we're looking for a similar 'signal' on certain cancer cells called PSMA. This signal isn't for mobile phones, though; it's a marker that can be seen using a special scan. This research focuses on various cancers affecting the digestive system, like those in the liver, bowel, pancreas, and bile ducts – what we call 'gastrointestinal cancers'.

The study uses an advanced scanning technique called 18F-PSMA PET/CT. This scan involves injecting a tiny amount of a safe, special substance that 'lights up' if it finds the PSMA marker on cancer cells. By doing this, we hope to achieve a few things. Firstly, we want to confirm that these types of cancer actually have the PSMA marker. Secondly, we want to see if this PSMA scan can find cancer areas more clearly or find spots that regular scans might miss. And finally, we want to understand if seeing this PSMA marker can help doctors predict how a patient might respond to their usual cancer treatments.

Ultimately, the goal of this research is to improve how we diagnose and understand these digestive system cancers. If successful, this special scan could become a valuable tool, helping doctors make more informed decisions about the best ways to treat people in the future.

Key takeaways

Looks for a marker (PSMA) on digestive system cancers.
Uses a special scan (PSMA PET/CT) to find cancer spots.
Aims to improve how doctors diagnose and understand these cancers.
You will receive standard cancer treatment, not experimental new drugs.
Participation involves an extra scan and allowing use of tissue samples and medical data.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and have recently been diagnosed with a gastrointestinal (stomach or gut) cancer. It's important that you haven't started your main cancer treatment yet and that doctors can get a small tissue sample from your cancer for testing. Both men and women can take part.

There are also some reasons why you might not be able to join. For example, if your cancer is already cured, or if there isn't enough tissue from your tumour for the necessary tests. Men who have had prostate cancer, or anyone who has had other types of cancer in the past, or who is pregnant or breastfeeding, won't be able to participate. Also, if there are medical reasons you can't have a PET/CT scan, you wouldn't be able to join.

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 old or older?
Have you recently been diagnosed with liver, bowel, pancreatic, or bile duct cancer?
Have you *not* started your main cancer treatment yet?
Can doctors get a small sample of your cancer tissue?
Are you able to have a special scan (PET/CT)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have a special scan called an 18F-PSMA PET/CT. We'll also need a small sample of your cancer tissue, which is usually collected during your diagnosis. You'll continue with the standard cancer treatment recommended by your doctors. The study team will follow your progress alongside your regular medical care. The length of your participation will depend on your treatment and follow-up schedule, but it will fit in with your existing appointments. The main commitment is attending the scan and allowing the research team to use information from your tissue samples and medical records.

Potential risks and benefits

Participating in this study might offer a potential benefit of gaining a deeper understanding of your specific cancer. While this study doesn't offer direct new treatment, the PSMA scan might provide doctors with additional information about your cancer that could be helpful for future treatment planning. As with any medical procedure, there are minor risks associated with the PET/CT scan, such as a small exposure to radiation (similar to a few X-rays) and possible mild reactions to the injected substance. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

University Hospital Wuerzburg
Verified postcode
Würzburg, Germany· Recruiting

Common questions

What kind of cancers is this study looking at?

This study is looking at various cancers of the digestive system, including liver, bowel, pancreas, and bile duct cancers.

What is PSMA?

PSMA is a specific marker or protein that can be found on the surface of some cancer cells, which the special scan can detect.

Will I receive new treatment in this study?

No, this study is about diagnosis and understanding your cancer better, not about giving new treatments. You will receive standard care from your doctors.

Are there any side effects from the scan?

The scan involves a small amount of radiation, similar to other X-rays, and a minor injection. Serious side effects are very rare, and the procedure is generally safe.

Do I have to pay to be in the study?

No, there are no costs for you to participate in this research study.

How to find out more

Alexander M Weich, MD

weich_a@ukw.de +4993120140201 Official trial record

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