AuthorisedTherapeutic exploratory (Phase II)Interventional

Fibroblast markers to tackle fibrosis in immune-mediated inflammatory diseases

This research is exploring a new type of imaging scan called 68Ga-FAPI-46 PET/CT. It's designed to help doctors find areas of 'fibrosis' – which is a type of scarring – in organs. This scarring can happen in people with ongoing inflammatory conditions like Crohn's disease, ulcerative colitis, and certain lung problems such as idiopathic pulmonary fibrosis (IPF) and unclassifiable interstitial lung disease (uILD). The study aims to see if the scan results match up with what's happening inside the body at a cell level. By understanding where and how this scarring occurs, researchers hope to get a clearer picture of these conditions, which could eventually lead to better ways to diagnose and manage them in the future. It's an early-stage study, meaning we're learning the basics about this new scanning technique.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Amsterdam UMC Stichting

Enrolment target

Start

02 Mar 2026

Idiopathic inflammatory myopathy (IIM)Crohn's disease (CD)Ulcerative colitis (UC)Fibrotic hypersensitivity pneumonitis (FHP)Idiopathic pulmonary fibrosis (IPF)Unclassifiable interstitial lung disease (uILD)Systemic sclerosis (SSc)

What is this study about?

This research study is about understanding and identifying 'fibrosis,' which is essentially a build-up of scar tissue in different organs of the body. Scarring can cause organs to work less well and is a common problem in several long-term inflammatory conditions, such as Crohn's disease and ulcerative colitis (which affect the gut), and various lung diseases like idiopathic pulmonary fibrosis and other interstitial lung diseases.

The study uses a special type of scan, called a 68Ga-FAPI-46 PET/CT scan. This scan is designed to light up areas where scar-forming cells, called fibroblasts, are particularly active. By using this scan, researchers hope to see if they can accurately pinpoint where scarring is happening in the body. They will then compare the scan results with other tests, such as blood tests and tissue samples, to see if the activity on the scan matches up with specific markers of scarring in the body.

The main goal is to figure out if this new scan can give doctors a better way to see and understand the scarring process in these conditions. This is an early-stage study (Phase II), meaning it's about exploring new ideas and gathering information. The hope is that a better understanding of fibrosis could eventually lead to improved ways to diagnose these conditions earlier and develop more effective treatments in the future. It's a step towards helping people live better with these chronic illnesses.

Key takeaways

This study uses a new scan to find scarring in organs.
It's for people with certain gut, lung, or muscle inflammatory conditions.
The scan aims to help doctors understand these diseases better.
Participation involves scanning and potentially blood/tissue tests.
This is an early-stage research study, not a treatment.
Taking part is voluntary and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. Both men and women can take part. You would need to have one of the specific inflammatory conditions being studied.

These conditions include various types of inflammatory muscle diseases (Idiopathic inflammatory myopathy), gut conditions like Crohn's disease and ulcerative colitis, and certain lung conditions such as fibrotic hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, unclassifiable interstitial lung disease, or a condition called systemic sclerosis.

There will also be other specific health requirements that the study doctors will check to make sure the study is safe and appropriate 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.

Are you 18 years old or older?
Do you have Crohn's disease, ulcerative colitis, or one of the specified lung or muscle inflammatory conditions?
Are you able to attend appointments for scans and tests?
Are you generally in good enough health to participate, apart from your main condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve undergoing a special scan called a 68Ga-FAPI-46 PET/CT scan. This scan helps doctors look for areas of scarring in your body. You would also have blood tests and, if appropriate for your condition, some tissue samples might be collected. These tests help compare what the scan shows with what's happening at a cellular level in your body. The researchers will also try to work out the best way to do this scan and measure the results. The exact number of visits and the full duration of your participation would be explained in detail by the study team if you are eligible and interested.

Potential risks and benefits

Potential benefits of taking part could include gaining new insights into your condition, and by contributing to this research, you could help doctors better understand and potentially treat these diseases in the future. The main risks would be those associated with the scan itself, which involves a small dose of radiation, similar to other medical scans. There might also be risks or discomfort associated with blood tests or tissue samples. All potential risks will be thoroughly explained to you, and you are always free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is 'fibrosis'?

Fibrosis is when scar tissue builds up in organs like your lungs or gut, which can stop them from working properly.

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

It's a special type of scan that can help doctors find areas in your body where scarring is actively happening, using a small amount of a tracing substance.

What kind of conditions are included in this study?

The study is looking at long-term inflammatory conditions affecting the muscles, gut (like Crohn's), and lungs (like idiopathic pulmonary fibrosis), as well as systemic sclerosis.

Will this scan treat my condition?

No, this scan is for research purposes to help us understand your condition better. It is not a treatment.

Do I have to take part?

No, taking part in any research study is completely voluntary. You can choose not to participate or withdraw at any time.