AuthorisedPhase II and Phase III (Integrated)Interventional

68Ga-FAPI-46 PET for imaging of gastrointestinal cancers: A prospective interventional single-arm clinical trial (FAPI-PET-GI)

This study, called FAPI-PET-GI, is looking at a new scanning method, the 68Ga-FAPI-46 PET scan, for finding various cancers of the digestive system. This includes cancers of the liver, bile ducts, stomach, pancreas, bowel, and food pipe. The main goal is to see how accurate this new scan is at identifying cancer in different parts of the body, confirmed by tissue samples. Researchers will also compare its performance to current standard scans. They will assess if it helps doctors make better treatment plans and keep an eye on any side effects. This is an important step in improving how these cancers are found.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Universitaetsklinikum Essen AöR

Enrolment target

150

Start

06 Mar 2025

Gastrointestinal cancers (including hepatocellular carcinoma cholangiocarcinoma gastric cancers pancreatic cancer colorectal cancer and oesophageal cancer)

What is this study about?

This study is focused on a new type of scan called a 68Ga-FAPI-46 PET scan. 'PET scan' stands for Positron Emission Tomography, which is a powerful imaging tool that can help doctors see inside the body. This particular PET scan uses a special substance, 68Ga-FAPI-46, which is designed to highlight cancer cells in the body.

The main purpose of the study is to find out how good this new FAPI-PET scan is at locating different types of digestive system cancers. These include cancers of the liver, bile ducts (small tubes that connect the liver to the bowel), stomach, pancreas, bowel (colon and rectum), and food pipe (oesophagus). Doctors want to see if this scan can pinpoint where the cancer is in the body, which is then confirmed by taking a small tissue sample (biopsy) or looking at tissue after surgery.

Researchers will also compare the FAPI-PET scan with the usual scans that patients currently have. They will check if the new scan finds more cancer, if it identifies where the cancer has spread within a region, further away, or to distant parts of the body more accurately, and if it helps doctors decide on the best treatment plan. They will also keep a close eye on any reactions or side effects patients might have to the scan, ensuring safety is a top priority.

Key takeaways

This study is testing a promising new scan for gut cancers.
It aims to improve how doctors find these cancers.
Participation involves having the new scan and being monitored.
The study assesses both the scan's accuracy and safety.
It compares the new scan to current standard imaging methods.

Who may be eligible?

This study is for adults aged 18 and over who have been diagnosed with certain types of digestive system cancers. These include cancers of the liver, bile ducts, stomach, pancreas, bowel, or food pipe. Both men and women can take part.

Detailed rules about who can join a study are important to make sure the results are clear and meaningful. Your doctor will need to check your medical history, current health, and any other treatments you're receiving to see if this study is suitable for you.

Since this is a phase II and phase III study, there will be very specific criteria to ensure patient safety and the quality of the research. Your doctor will discuss all the requirements with you.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of cancer in your liver, stomach, pancreas, bowel, food pipe, or bile ducts?
Are you able to attend appointments for imaging scans?
Are you able to agree to the study requirements?

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

What does participation involve?

The study involves having the new 68Ga-FAPI-46 PET scan. You will likely have this scan in addition to any standard scans you would normally have as part of your cancer journey. Before and after the scan, doctors involved in your care might be asked to fill out questionnaires about how the scan results might change your treatment plan. Throughout the study, medical staff will carefully monitor your health, including your vital signs (like blood pressure and heart rate) and conduct blood tests to check for any changes. The total duration of your participation will depend on the study design and your personal treatment plan, but it's mainly focused on the initial assessment of the scan's effectiveness and safety.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new, potentially more accurate scan that could improve how your cancer is detected and managed. However, as with any medical procedure or research, there are potential risks, such as side effects from the scan's tracer or radiation exposure, though these are typically carefully controlled and monitored. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your standard medical care.

Locations (1)

—
Germany

Common questions

What is a 68Ga-FAPI-46 PET scan?

It's a new type of imaging test that uses a special substance to help doctors see certain types of cancer cells in the body more clearly.

Which cancers are being studied?

The study looks at several cancers of the gut, including those of the liver, stomach, pancreas, bowel, and food pipe.

Will this scan replace my usual scans?

No, primarily it's being tested alongside your standard scans to see if it offers additional useful information.

What happens if I join the study?

You will have the new scan, and your health will be closely monitored. Doctors may adjust your treatment based on these new findings, if relevant.

Is there radiation involved?

Yes, PET scans use a small amount of radiation, similar to other medical imaging tests. The amount is carefully controlled.