RecruitingOBSERVATIONAL

Fibrosis Associated Protein Inhibitor (FAPI) Radiotracer-based Imaging to Identify Fibrotic Intestinal Crohn's Disease

Crohn's disease can cause lasting scarring in the gut, often leading to surgery. Current treatments focus on reducing inflammation, but there's no good way to find or treat this scarring. This study is exploring a new imaging technique to detect scarring using a special 'dye' (called FAPI). This dye shows up on scans (PET/CT) and helps doctors see how active the scarring is. If successful, this could be a big step forward. It could help doctors spot scarring early, track how it changes, and create new medicines to stop it from getting worse, ultimately improving life for people with Crohn's disease.

At a glance

Status

Recruiting

Sponsor

University of Edinburgh

Enrolment target

Start

01 Sep 2024

Estimated completion

01 Aug 2028

Crohn Disease

What is this study about?

If you have Crohn's disease, you know it's a long-lasting condition that can affect your gut. While treatments have improved over the years to help with inflammation, many people still develop scarring in their bowel, which can lead to surgery. Doctors currently don't have a good way to see this scarring, especially in its early stages, or to tell how severe it is.

This study aims to change that. Researchers are looking at a new method that uses a special 'dye' called FAPI. This dye is designed to attach to cells linked with scarring in the intestine. By using this dye along with special scans (called PET/CT scans), doctors hope to be able to see where the scarring is, how much there is, and how active it is.

Being able to accurately identify and track scarring would be a huge breakthrough. It could help doctors understand how scarring progresses and guide the development of new treatments specifically designed to prevent or reduce this bowel damage. The ultimate goal is to improve the care and long-term health for people living with Crohn's disease.

Key takeaways

Crohn's disease can lead to gut scarring, often requiring surgery.
Current treatments focus on inflammation, not scarring itself.
This study is testing a new 'dye' (FAPI) to find and track gut scarring.
The FAPI dye shows up on special PET/CT scans.
If successful, this could revolutionise how scarring is managed and help develop new treatments.

Who may be eligible?

This study is looking for adults aged 18 to 90 years old who have Crohn's disease. Specifically, they are looking for people whose Crohn's disease affects the last part of their small intestine (called the ileum) or who have a recurrence of the disease in that area after surgery. You would also need to be starting a new type of medicine called biologics.

However, there are also some reasons why you might not be able to take part. For example, you can't be pregnant or breastfeeding. You also can't take part if you have kidney problems, certain metal implants in your body (which can be an issue for the MRI scan), or if you’re severely claustrophobic and can’t lie still for a scan.

Other reasons you might not be eligible include having an allergy to certain dyes used in scans, or if your Crohn's disease only affects your large intestine and not your small intestine. This study needs people who can comfortably give their consent and don't have significant mental health conditions that would make it hard to understand or participate.

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 between 18 and 90 years old?
Do you have Crohn's disease affecting your small intestine (ileum)?
Are you about to start a new biologic medication?
Are you *not* pregnant or breastfeeding?
Do you feel comfortable lying still for scans and don't have severe claustrophobia?
Do you *not* have severe kidney problems or certain metal implants?

Answer every question to see your result.

What does participation involve?

The description does not provide details on the number of visits, specific assessments beyond PET/CT scans, medication interactions (other than starting biologics), follow-up duration, or the total duration of study participation. This information would typically be explained in more detail by the study team if you are considered for the trial.

Potential risks and benefits

Participating in this study could offer you the potential benefit of contributing to new knowledge that might one day lead to better ways of detecting and treating scarring in Crohn's disease. However, there are potential risks, such as side effects from the special `dye` (FAPI) or contrast agents, and exposure to radiation from the PET/CT scans, though this is carefully monitored. You will be fully informed of all known risks before you decide, and remember that you always have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

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

NHS Lothian
Verified postcode
Edinburgh, United Kingdom· Recruiting

Common questions

What is 'fibrosis' in Crohn's disease?

Fibrosis is when scar tissue builds up in your gut. Over time, this scarring can narrow your bowel and may lead to needing surgery.

What is FAPI?

FAPI stands for Fibrosis Associated Protein Inhibitor. It's a special 'dye' that doctors hope can attach to and highlight scar tissue in your body during scans.

What are PET/CT scans?

PET/CT scans are imaging tests that combine two types of scans to create detailed pictures of your body. They can help doctors see how your organs are working and identify problems like scarring.

Will this study help my Crohn's disease directly?

The main goal of this study is to develop a new way to detect scarring. While it may not directly change your current treatment, the information learned could help future patients and lead to new scar-preventing medicines.

Is the FAPI dye safe?

All substances used in medical studies are carefully checked for safety. The research team will explain any potential risks and side effects of the FAPI dye before you decide to take part.

How to find out more

Rahul Kalla, MBChB PhD

rahul.kalla@ed.ac.uk 0131 651 8100 Official trial record

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