AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

In situ injection of anti-angiogenics in patients with brain arteriovenous malformations not eligible for exclusion treatment: phase I trial (BLITZ)

This study is investigating a new type of treatment for adults who have a rare brain condition known as an arteriovenous malformation (AVM). An AVM is basically a tangle of blood vessels that can sometimes cause problems. For people who aren't suitable for existing treatments, like surgery or radiation, this study is exploring a new approach. The treatment involves injecting a special medicine directly into the AVM in the brain. This medicine is designed to help shrink or reduce the blood vessels in the AVM. This is a "Phase I" study, which means it's one of the first times this treatment is being tested in humans. The main goal is to check how safe it is and how well people tolerate it, rather than primarily looking at how effective it is at this stage. It's an important step in finding new ways to help those with AVMs.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

27 Jan 2025

Cardiology and vascular disease

What is this study about?

This research study is looking into a new way to treat a condition called a brain arteriovenous malformation, often shortened to AVM. Imagine your blood vessels as a neat network of roads. With an AVM, some of these roads get jumbled up and tangled. These tangles can sometimes cause complications, so doctors look for ways to treat them.

For many patients, AVMs can be treated with surgery or other methods. However, this study is specifically for adults who have an AVM in their brain but aren't suitable for these standard treatments. The scientists are testing a new approach which involves giving an injection directly into the AVM. This injection contains medicines designed to specifically target and reduce the abnormal blood vessels in the tangle.

Because this is a very new treatment, this study is a "Phase I" trial. This means the main goal is to carefully check if the new injection is safe for people and how their bodies react to it. It's like taking the first cautious steps to see if a new path is safe to walk on, before looking at how quickly you can travel along it. The information gathered from this study will be crucial for deciding if this treatment can be further developed to help more people with AVMs in the future.

Key takeaways

This study explores a new injection for specific brain AVMs.
It's for adults whose AVMs can't be treated by usual methods.
The main aim is to check the treatment's safety in people (Phase I trial).
Participation involves an injection, follow-up visits, and monitoring.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or over. This study is open to both men and women.

Crucially, you would only be eligible if you have a brain AVM that doctors have determined cannot be treated effectively by existing methods, such as surgery or other established procedures. The doctors involved in the study would need to review your specific medical情况 to confirm if you meet these detailed criteria.

There may be other specific medical reasons or conditions that would mean you can't take part, to ensure the safety of everyone in the study. These will be discussed fully with you by the research team.

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 a brain AVM?
Have your doctors told you that your AVM can't be treated by standard methods?
Are you able to attend regular follow-up appointments and assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a number of checks to make sure your medical condition matches what the study needs. If you are eligible, you would receive the special injection directly into your brain AVM. This procedure would be carefully planned and carried out by specialist doctors.

After the injection, you would have regular appointments and tests. These might include scans, blood tests, and check-ups with the study doctors. These visits are very important for the researchers to monitor how you are doing, how your body is reacting to the treatment, and to look for any changes in your AVM. The total length of your participation, including follow-up visits, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in a study like this always involves careful consideration. Potential benefits might include gaining access to a new treatment for your AVM if other options aren't suitable, and contributing to medical knowledge that could help future patients. However, as this is a new treatment, there could be risks that aren't fully known yet, such as side effects from the injection or the procedure itself. The research team will explain all known and potential risks to you clearly. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
France

Common questions

What is an AVM?

An AVM (Arteriovenous Malformation) is an unusual tangle of blood vessels in the brain that connects arteries and veins directly, bypassing the normal network of capillaries.

What does 'Phase I' mean in a study?

A Phase I study is the first stage of testing a new treatment in people. Its main purpose is to check if the treatment is safe and to find the right dose, rather than how well it cures a condition.

Will this injection cure my AVM?

The main goal of this particular study is to check the safety of the new injection and how the body reacts to it. While it's hoped to have an effect on AVMs, it's not primarily designed to promise a cure at this early stage.

Will I have to pay to be in the study?

No, typically participation in clinical trials in the UK means that treatment and study-related assessments are provided without charge to the patient.

Can I leave the study at any time?

Yes, your participation is completely voluntary. You can decide to leave the study at any point, and this won't affect your medical care.