RecruitingNAINTERVENTIONAL

Treatment of Brain AVMs (TOBAS) Study

The TOBAS Study aims to find the safest and most effective treatments for brain arteriovenous malformations (AVMs) in the long term. AVMs are tangled blood vessels in the brain that can sometimes lead to bleeding, seizures, or other problems. Doctors are studying different options, including surgery, radiation therapy, and embolization (a procedure to block blood flow to the AVM), or carefully monitoring the AVM without active treatment. For AVMs that haven't bled, the study wants to see if treatment can significantly lower the risk of death or disabling stroke. For those that have bled, or to generally improve treatment, they are looking at whether embolization can make surgery or radiation therapy more successful and safer. The goal is to provide the best possible care for people with AVMs.

At a glance

Status

Recruiting

Phase

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

1,000

Start

01 May 2014

Estimated completion

01 Jan 2036

Unruptured Brain Arteriovenous Malformation Ruptured Brain Arteriovenous Malformation Arteriovenous Malformations AVM BAVM

What is this study about?

The TOBAS Study is exploring the best ways to manage a condition called a brain AVM. An AVM is like a tangle of blood vessels in your brain that shouldn't be there. While they are not very common, they can sometimes cause serious problems like bleeding in the brain or seizures. Often, doctors discover AVMs when someone has a scan for something else, or if they experience symptoms like a headache or seizure.

Because AVMs can be serious, doctors are keen to find the most effective and safest treatments. There are different approaches, including surgery (where doctors remove the AVM), radiation therapy (using focused radiation to shrink the AVM), or embolization (a procedure where doctors inject a substance to block the AVM's blood supply). Sometimes, doctors might suggest a combination of these treatments, or in some cases, they might recommend carefully watching the AVM without active treatment. This study wants to find out which of these options leads to the best long-term results for patients.

Specifically, the study has a couple of main goals. For AVMs that haven't bled yet, it wants to see if treating them can reduce the chance of serious problems like death or a debilitating stroke by a significant amount over ten years. For AVMs that are being treated with surgery or radiation, the study is also looking at whether adding embolization beforehand can make these treatments safer and more successful. By comparing these different options, the study hopes to reduce treatment failures and provide clearer guidance for doctors and patients in the future.

Key takeaways

The study aims to find the best long-term treatments for brain AVMs.
It's comparing surgery, radiation, embolization, and careful watching.
It wants to know if treatments can reduce risks like death or stroke.
It's also checking if embolization can make other treatments more successful.
The study is for people with AVMs, aged 5 and over.
Participation involves monitoring and standard treatments.

Who may be eligible?

The TOBAS Study is generally looking for anyone who has been diagnosed with an AVM in their brain. This includes people whose AVM has caused bleeding and those where it hasn't, and it's open to people aged 5 years and older. Your doctor will help decide if this study might be right for you.

However, you wouldn't be able to join the study if you have had bleeding from your AVM that was so severe you needed urgent surgery. But if, after that initial surgery, some of the AVM still remains, you might then be considered for the TOBAS Study. The doctors need to make sure the study design is fair and won't put anyone at unnecessary risk.

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.

I have been diagnosed with a brain AVM.
I am aged 5 years or older.
I did not need emergency surgery for a serious AVM bleed.
I understand my doctor will decide if the study is suitable for me.

Answer every question to see your result.

What does participation involve?

If you decide to take part in the TOBAS Study, you will be carefully monitored over a period of time. This will involve regular check-ups with your medical team and likely brain scans to keep an eye on your AVM and how you are doing. Depending on what your doctors decide is best for you and your AVM, your treatment might involve surgery, radiation therapy, or embolization. The specific number of visits and tests will depend on your individual treatment plan. The study will track your health and the outcome of your AVM over a long period to understand the long-term effects of the treatments. You won't be given any experimental medication unless it's part of a standard treatment being compared.

Potential risks and benefits

Taking part in this study may offer the benefit of receiving close monitoring and potentially a treatment chosen specifically to give you the best long-term outcome based on current medical understanding. However, as with any medical treatment, there are potential risks associated with surgery, radiation therapy, and embolization, which your doctors will discuss fully with you. There are also risks linked to the AVM itself, whether treated or not. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

Mayo Clinic in Jacksonville FL
Verified postcode
Jacksonville, United States· Recruiting
Boston Medical Center
Verified postcode
Boston, United States· Recruiting
University of New Mexico Health Sciences Center
Verified postcode
Albuquerque, United States· Recruiting
Hospital Geral de Fortaleza
Verified postcode
Fortaleza, Brazil· Recruiting
Universidade Federal de Sǎo Paulo
Verified postcode
São Paulo, Brazil· Recruiting
University of Alberta Hospital
Verified postcode
Edmonton, Canada· Recruiting
Klink, Ruby
Verified postcode
Montreal, Canada· Recruiting
Instituto de Neurocirugia Dr. A. Asenjo
Verified postcode
Santiago, Chile· Recruiting
Universidad Autonoma de Bucaramanga
Verified postcode
Bucaramanga, Colombia· Recruiting
CHRU de Brest (Brest University Hospital)
Verified postcode
Brest, France· Recruiting
Centre Hospit Régional Universitaire de Besançon
Verified postcode
Besançon, France· Recruiting
Centre Hospitalier Universitaire de Bordeaux
Verified postcode
Bordeaux, France· Recruiting

Common questions

What is an AVM?

An AVM (Arteriovenous Malformation) is an uncommon condition where blood vessels in your brain form a tangle instead of the normal, organised connections. This can sometimes cause problems.

What kind of treatments are being looked at?

The study is looking at several common treatments including surgery (removing the AVM), radiation therapy (using focused rays to shrink it), and embolization (blocking blood flow to the AVM). Sometimes, carefully watching the AVM is also an option.

Why is this study important?

This study is important because it aims to find out which of the treatments, or combinations of treatments, offer the best long-term outcomes for patients with AVMs, helping doctors make better decisions.

Will I have to take new medication?

The study focuses on procedures like surgery, radiation, and embolization, or careful monitoring. You won't be given experimental medication specifically for the study, but you'll continue with any medications your doctor thinks you need for your health.

What if my AVM has already bled?

The study includes people whose AVMs have bled, as well as those that haven't. However, if you needed emergency surgery for a serious bleed, you might not be able to join initially, but could be considered later if some AVM remains.

How to find out more

Daniel Roy, MD

daniel.roy.chum@ssss.gouv.qc.ca 514-890-8000 Official trial record

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