RecruitingNAINTERVENTIONAL

68Gallium-FAPI46 PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases

This study is investigating a new type of scan called 68Ga-FAPI PET/CT for people living with long-term inflammatory and scarring conditions. These conditions include things like rheumatoid arthritis, certain liver problems, and lupus. The goal is to see if this new scan can give doctors a clearer picture of these diseases than current methods. By highlighting specific 'activated' cells involved in inflammation and scarring, the researchers hope this scan could help diagnose conditions more accurately and monitor how they change over time. This could lead to better personal care plans for patients. This initial study will look at 13 different conditions to understand where this new scanning technique might be most useful.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Brest

Enrolment target

390

Start

13 Mar 2025

Estimated completion

21 Sep 2027

Inflammatory Disease

What is this study about?

Imagine doctors have a new special camera that can see very specific things inside your body related to inflammation and scarring. That's essentially what this study is exploring with a new type of scan called 68Ga-FAPI PET/CT. This scan uses a small amount of a special tracer, called 68Ga-FAPI, which attaches itself to certain cells called 'fibroblast activation protein' (FAP) that are very active when there's inflammation or scarring.

At the moment, doctors have different ways to diagnose and keep an eye on conditions like rheumatoid arthritis, liver scarring (fibrosis), and lupus. However, sometimes it's hard to get a really clear picture of exactly what's happening. This new scan aims to provide a more precise view, potentially helping doctors understand the disease better, diagnose it earlier, and track if treatments are working.

Initially, this particular study will look at 13 different long-term inflammatory and scarring conditions. The researchers want to find out where this new scan could be most helpful. If it proves useful, it could eventually become a valuable tool in routine care to improve how doctors understand and manage these conditions, leading to more tailored care for patients.

Key takeaways

New scan (68Ga-FAPI PET/CT) being studied for inflammatory/scarring conditions.
Aims to improve diagnosis and monitoring of diseases like arthritis or liver scarring.
Trial is an early step to see where this scan could be most useful.
Participation helps advance medical understanding.
Focuses on specific cells active during disease.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be 18 years old or older and have one of the specific inflammatory or scarring conditions being investigated. You'll also need to meet the standard medical definitions for that condition.

There are also some important reasons why you might not be able to join. You cannot take part if you are pregnant or breastfeeding, or if you have an active cancer diagnosis. Also, if you are a woman who could become pregnant, you'd need to agree to use effective birth control during the study.

Finally, you need to be able to understand the study information and agree to take part. If you are unable to give consent, or simply don't want to participate, then this study isn't 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 a long-term inflammatory or scarring condition?
If you are a woman of childbearing potential, are you able to use contraception?
Do you not have an active cancer diagnosis?
Are you able to understand the study and agree to take part?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

This is a pilot study, which means it's an early look at this new scanning technique. If you join, you would undergo the 68Ga-FAPI PET/CT scan. The study will involve a team of doctors and specialists checking your health against the study's requirements. You will likely have regular check-ups and assessments to track your condition. The main focus is the new scan, and the total duration or number of visits isn't specified but would be discussed fully with you before you agree to take part.

Potential risks and benefits

Taking part in this study may offer the potential benefit of helping medical science understand inflammatory and scarring diseases better. While there's no guarantee of direct personal benefit, your participation could contribute to improving future diagnosis and treatment for others. As with any medical procedure, there are potential risks associated with the scan itself, such as a small exposure to radiation from the tracer. These risks will be explained in detail by the study team. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Chu Brest
Verified postcode
Brest, France· Recruiting

Common questions

What is 68Ga-FAPI PET/CT?

It's a new type of imaging scan that uses a special tracer to highlight cells active in inflammation and scarring, helping doctors see these processes more clearly.

What kind of conditions is this study looking at?

It's focusing on a range of long-term inflammatory and scarring conditions, for example, rheumatoid arthritis, certain liver diseases, and lupus.

Will I get direct benefit from taking part?

While there's no guarantee of direct personal medical benefit, your participation will help scientists learn more about these diseases, which could lead to better treatments in the future.

What are the main reasons I might not be able to join?

You wouldn't be able to join if you are pregnant, breastfeeding, have active cancer, or cannot give your consent to participate.

Is the scan safe?

The study team will explain all the potential risks, including a small amount of radiation exposure from the tracer, to ensure you are fully informed and comfortable.

How to find out more

Pierre-Yves LE ROUX, PHD

pierre-yves.leroux@chu-brest.fr +33 (0) 229020266 Official trial record

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