AuthorisedTherapeutic exploratory (Phase II)Interventional

CAT-VHL - Exploring the role of Carbonic Anhydrase IX as diagnostic and Theranostic target in Von-Hippel Lindau disease

This study, called CAT-VHL, is testing a new type of imaging scan to detect tumours in people with a rare condition called Von Hippel-Lindau (VHL) disease. VHL disease can cause non-cancerous and cancerous growths in different parts of the body. The scan uses a special substance called Zr-DFO-girentuximab that helps highlight these tumours. Researchers want to see how accurate this scan is at finding tumours and how safe it is for patients. This is an early-stage study, hoping to improve how doctors find and check on tumours in people with VHL disease, potentially leading to earlier treatment.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ospedale San Raffaele S.r.l.

Enrolment target

Start

24 Oct 2025

Von-Hippel Lindau (VHL) Disease

What is this study about?

Von Hippel-Lindau (VHL) disease is a rare genetic condition that can cause tumours to grow in various parts of the body, including the brain, spinal cord, eyes, kidneys, and pancreas. While many of these tumours are not cancerous, some can be. Finding these tumours early is very important for proper care and treatment. This study is exploring a new way to do just that, using a special type of scan.

The study, named CAT-VHL, is looking at a new imaging test that uses a substance called Zr-DFO-girentuximab along with a PET scan. Think of it like a special dye that highlights specific areas. In VHL disease, some cells in tumours produce a particular protein called Carbonic Anhydrase IX (CAIX). The substance used in this scan is designed to attach to this CAIX protein, making the tumours show up more clearly on the scan. The main goal is to find out how well this scan can detect tumours in people with VHL disease.

Researchers also want to check how accurate this scanning method is and importantly, confirm that it's safe for patients. By learning more about this scan, doctors hope to get a clearer picture of tumours in VHL patients, which could help them make better decisions about treatment and care. This is a crucial step towards improving the lives of people living with VHL disease.

Key takeaways

This study is testing a new type of scan to find tumours in people with VHL disease.
The scan uses a special substance that helps highlight specific tumour cells.
The main goals are to see how accurate and safe this new scanning method is.
Better tumour detection could lead to earlier and more effective tailored treatment.
It's open to adults aged 18 and older diagnosed with VHL disease.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate in this research.

However, since this study focuses on detecting tumours in people with Von Hippel-Lindau (VHL) disease, you would need to have a diagnosis of VHL disease to be considered. The study is specifically designed for VHL patients to understand how well the new scan works in their condition.

Before you can join, the study team will carefully check your medical history to make sure the study areas match your current health situation. This is to ensure your safety and that the study is right 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 diagnosis of Von Hippel-Lindau (VHL) disease?
Are you able to attend study appointments as required?
Are you comfortable with undergoing medical scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a special scan called a CAIX-PET scan. The exact number of visits and the full timeline for your involvement will be discussed in detail by the study team. You might have one or more scan appointments, and there will likely be follow-up checks to see how things are going and to assess the safety of the new scanning method.

During your visits, you would have the special substance (Zr-DFO-girentuximab) administered, usually by injection, before the PET scan. The scan itself is similar to other medical scans and is not usually uncomfortable. The total duration of your participation, from your first visit to your last follow-up, will be clearly explained by the research team if you are eligible and interested.

Potential risks and benefits

Participating in this study might offer the benefit of a detailed scan of your body, which could help in finding or monitoring tumours related to your VHL disease. This new scanning method could potentially lead to earlier detection or more precise information for your doctors. As with any medical procedure, there are potential risks, such as side effects from the imaging substance, which will be fully explained to you before you agree to take part. You have the right to withdraw from the study at any time, for any reason, without it 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
Italy

Common questions

What is Von Hippel-Lindau (VHL) disease?

VHL disease is a rare genetic condition that can cause tumours to grow in different parts of your body, like the brain, kidneys, and eyes. Some are harmless, others can be serious.

What is the new scan called?

The new scan tested in this study is called a CAIX-PET scan. It uses a special tracer to highlight tumours.

Why is this study important for VHL patients?

This study aims to find a better way to detect tumours in VHL patients earlier and more accurately, which could improve treatment decisions and overall care.

Can I still get my usual VHL care if I join the study?

Yes, joining a study like this does not replace your routine medical care for VHL disease. Your doctors will continue to manage your condition as usual.

Is the new scan safe?

Researchers will carefully check the safety of the scan. Any known risks will be clearly explained to you by the study team before you decide to participate.