AuthorisedTherapeutic exploratory (Phase II)Interventional

Treatment of low-flow vascular malformations with bleomycin electrosclerotherapy (BEST)

This study is investigating a treatment called Bleomycin Electrosclerotherapy (BEST) for low-flow vascular malformations. These are types of birthmarks where blood vessels haven't formed correctly. The main goal is to check how well this treatment can shrink the birthmarks, using MRI scans three months after treatment. We'll also look at whether the effects last for a year, if the study plan is practical, and if the treatment is safe and tolerable for adults. Patient's quality of life will also be assessed. The study is open to anyone aged 18 or older who has one of these vascular malformations. It's a Phase II study, meaning it's exploring the treatment's effectiveness.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institute Of Oncology Ljubljana

Enrolment target

140

Start

07 Apr 2026

VASCULAR MALFORMATION

What is this study about?

This study is looking into a new treatment for something called a vascular malformation. These aren't common, but they're basically a tangled group of blood vessels that didn't form properly before birth. They can be found anywhere in the body and might cause pain, swelling, or other issues depending on where they are.

The treatment being studied is called Bleomycin Electrosclerotherapy, or BEST for short. This involves using a medicine called bleomycin directly in the malformation, combined with a special electrical treatment. The idea is to make the abnormal blood vessels shrink over time.

We want to see how well BEST works to shrink these malformations. We'll measure this using special scans called MRIs about three months after the treatment. We also want to make sure the treatment is safe for patients and see how it affects their daily life. This is an important step in finding better ways to manage these conditions.

Key takeaways

This study evaluates a new treatment (BEST) for vascular malformations.
It aims to see if BEST can shrink these birthmarks in adults.
The treatment involves a medicine and electrical therapy.
Effectiveness will be checked with MRI scans.
Safety and impact on quality of life are also being studied.
Open to adults aged 18 and over.

Who may be eligible?

This study is for adults who have a low-flow vascular malformation. This is a specific type of abnormal blood vessel growth that is present from birth.

To be considered for this study, you need to be at least 18 years old. The study is open to both men and women.

There may be other specific health requirements or conditions that mean you can or cannot take part. These would be discussed in detail with the study 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 low-flow vascular malformation (a type of birthmark)?
Are you able to attend appointments for treatment and follow-up scans?
Are you comfortable with receiving a new type of treatment?

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 full assessment to make sure it's the right choice for you. The treatment involves receiving the bleomycin medicine along with the electrical treatment. You would then have follow-up appointments, including MRI scans, to check the size of your vascular malformation. There will also be appointments to check on your general health, any side effects, and your quality of life. The main check-up for how well the treatment works will be at 3 months, with another check at 12 months. The full duration of your participation would be at least 12 months.

Potential risks and benefits

Taking part in a study like this might have potential benefits, such as receiving a new treatment that could help shrink your vascular malformation. However, there's no guarantee the treatment will work for everyone, and it's possible it might not work for you. As with any medical treatment, there could be side effects or risks, which the study team will explain in detail. 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
Slovenia

Common questions

What is a low-flow vascular malformation?

It's a type of birthmark where blood vessels grew abnormally, leading to a slow flow of blood. They are present from birth.

What is bleomycin electrosclerotherapy (BEST)?

It's a treatment that uses a medicine called bleomycin injected into the malformation, combined with a special electrical treatment to help shrink the abnormal blood vessels.

How will I know if the treatment is working?

The study will use MRI scans to measure the size of your malformation, primarily at 3 months and again at 12 months after treatment.

How long will I be involved in the study?

Your participation will typically last for at least 12 months, including treatment and follow-up appointments.

Will I have to pay to be in this study?

No, you will not have to pay for the study treatment or assessments. Study participation is usually free of charge.