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AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

Targeting fibrotic tissue with a radioactive-labelled Fibrobody, visible using a full-body PET/CT scan (FibroVision)

Many chronic health conditions cause internal scarring, known as fibrosis, which can damage organs such as the lungs, liver, and kidneys. Currently, doctors find it difficult to track this scarring without taking physical tissue samples (biopsies). The FibroVision trial is testing an experimental imaging tool. Participants are given a tiny injection of a substance called a Fibrobody. This substance has a small, safe radioactive tag that attaches to scar tissue. A full-body PET/CT scanner then takes pictures to see where the tracer goes and how clearly the scarring shows up. This is a Phase 1 clinical trial, meaning it is the very first time the Fibrobody is being tested in people. The main goal is to check its safety and see how well it works in adults living with conditions that cause organ scarring.

At a glance

What is this study about?

When organs like the lungs, kidneys, or liver become injured or inflamed over a long time, the body tries to repair them by forming tough scar tissue. This process is called fibrosis. Over time, too much scarring can stop these vital organs from working properly. At the moment, it can be hard for doctors to measure how much scarring is present across the whole body without invasive procedures like biopsies.

The FibroVision study aims to solve this problem by testing a new scanning technique. Researchers have developed a special molecule called a 'Fibrobody'. This molecule is designed to seek out and stick to active scar tissue. By adding a tiny, harmless radioactive marker to the Fibrobody, doctors can use a PET/CT scanner to take clear pictures of internal scarring from head to toe.

Because this is a Phase 1 study, it is the first time the Fibrobody is being given to humans. The research team wants to ensure the injection is safe, see how it moves through the body, and learn how quickly it leaves the system. If successful, this new scan could help doctors spot organ damage earlier and monitor future treatments much more easily.

Key takeaways

  • FibroVision is testing a new full-body scan designed to highlight organ scarring (fibrosis).
  • It uses a tiny amount of an experimental tracer called a Fibrobody to light up scars on a PET/CT scanner.
  • This is a Phase 1 study, testing the safety of the tracer in humans for the first time.
  • The trial is open to adults with scarring conditions affecting the lungs, liver, kidneys, or blood vessels.
  • Participation involves health checks, a single tracer injection, and a hospital imaging scan.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with certain health conditions that cause organ scarring. These include long-term conditions affecting the lungs (such as idiopathic pulmonary fibrosis or pulmonary arterial hypertension), the kidneys (chronic kidney disease), or the liver (such as fatty liver disease or primary sclerosing cholangitis). People who carry a specific gene change called a BMPR2 mutation may also be able to join.

You might not be able to take part if you are pregnant or breastfeeding, as the scan uses a low dose of radiation. People with severe allergies, or those who cannot safely lie flat inside a PET/CT scanner for the required time, may also be excluded.

Your clinical team will look at your overall health and medical history to check whether taking part is safe and suitable 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.

  1. I am aged 18 or older.
  2. I have a diagnosed condition that causes organ scarring (such as kidney disease, lung fibrosis, or liver disease).
  3. I am not currently pregnant or breastfeeding.
  4. I am comfortable lying flat and still inside a scanner for up to an hour.
  5. I am able to travel to the study hospital for appointments.
Answer every question to see your result.

What does participation involve?

Taking part usually involves one or two visits to a specialist hospital imaging centre. Before the scan, doctors will check your health with simple tests, such as checking your blood pressure and taking a blood sample.

On the day of the scan, you will receive a small injection of the Fibrobody tracer into a vein in your arm. You will then rest comfortably while the tracer travels through your body. Afterwards, you will lie flat on a padded bed that slowly moves through a PET/CT scanner, which takes pictures of your organs. The scanning process usually takes under an hour.

The study team will monitor you closely for any side effects before you go home. You may have a short follow-up telephone call or brief clinic visit a few days later to check how you are feeling. The entire study commitment typically lasts only a few weeks from your first check-up to the final follow-up.

Potential risks and benefits

Because this is an imaging study, taking part will not cure or treat your condition directly, but it could help improve how doctors detect and treat organ scarring for others in the future. The main risks involve mild discomfort or bruising from the injection needle, and a small amount of radiation from the tracer and PET/CT scan. This radiation level is kept as low as possible and is similar to other routine hospital scans. As with any new medicine, there is a small chance of an allergic reaction or unexpected side effect, but doctors will monitor you throughout. Taking part is completely voluntary, and you can change your mind and leave the study at any time without it affecting your usual NHS care.

Locations (1)

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

Common questions

Will this scan cure my condition?

No. This study is testing an imaging tool to take pictures of scarring, not a treatment to cure your illness.

Is the radioactive tracer safe?

Yes. The amount of radiation used is very small and kept to a safe level, similar to standard medical scans. It fades quickly and leaves your body naturally in your urine.

Does the scan hurt?

The scan itself is completely painless. You may feel a brief pinch when the small needle is placed in your arm for the injection.

Will taking part cost me anything?

No. The scans and study tests are free. Many clinical trials also help cover reasonable travel expenses to and from the hospital.

What happens if I decide to stop?

You are free to leave the trial at any point. Your decision will not change the standard of care or support you receive from your normal doctors.

How to find out more

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

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