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A study to evaluate the effectiveness of bleomycin sulfate for treating patients with low-flow vascular malformations using electrosclerotherapy.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on the treatment of vascular malformations, which are abnormal growths of blood vessels. Specifically, the research looks at low-flow vascular malformations, a type where blood moves slowly through the affected area. The goal of the study is to determine the effectiveness and feasibility of a treatment method called electrosclerotherapy using the drug bleomycin. This process involves using a specialized technique to deliver the medication directly into the abnormal vessels to help shrink them.

The medication used in this procedure is bleomycin sulfate, which is administered as a solution for injection. During the study, participants undergo the treatment, and their progress is monitored over time. This includes using MRI, a type of imaging that uses magnetic fields to create detailed pictures of the body, to check for changes in the size of the affected area. The follow-up periods occur at three months and twelve months after the procedure to evaluate how well the treatment worked and to monitor any side effects.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment with bleomycin
An injection of bleomycin is administered. The amount used is 30 mg/kg, which means 30 milligrams of the medicine for every kilogram of body weight.
Step 2
Follow-up assessments
An MRI (a medical scan that uses magnetic fields to create detailed images of the inside of the body) is performed 3 months after the treatment to measure changes in the size of the vascular malformation (an abnormal connection of blood vessels).
Step 3
Long-term evaluation
A further assessment is conducted 12 months after the treatment to evaluate the continued effectiveness of the procedure.
Information regarding quality of life is collected using a standard questionnaire called OVAMA.

Who can join the trial?

8 criteria

You must have a low-flow vascular malformation, which is a group of abnormal blood vessels (such as veins, lymph vessels, or capillaries) where blood moves through them very slowly.
The malformation can be of the venous (vein), lymphatic (part of the fluid drainage system), capillary (smallest blood vessels), or mixed type.
You must have a malformation that has not responded well to previous treatments or one that has come back after being treated.
It must be technically feasible to perform the procedure, meaning doctors must be able to safely inject the medicine bleomycin (a type of drug used in the treatment) and safely place electrodes (small devices used to deliver energy) into the malformation.
You must be 18 years of age or older.
The longest part of the affected area must not be larger than 25 cm.
Multiple areas can be treated, as long as the total amount of medicine used does not exceed the limit of 10,000 IU (International Units, a measure of medicine amount) per treatment session.
The affected area can be on the skin, the mucosa (the moist lining of body openings), or located either near the surface or deep inside the body.

Who cannot join the trial?

10 criteria

Being pregnant or breastfeeding (lactation).
Having chronic renal dysfunction, which means your kidneys (the organs that filter your blood) are not working properly over a long period of time.
Adults who have previously taken a medicine called bleomycin and received a total amount higher than 100,000 IU.
Having abnormal respiratory results or chest pathology, which refers to any lung or chest problems, including having had severe or long COVID-19.
Having a known allergy or hypersensitivity, which means your body has an unusually strong or harmful reaction, to the medicine bleomycin.
Having significant central venous drainage that prevents sclerotherapy (a medical procedure where a liquid is injected into a vessel to close it off).
Women who are able to become pregnant and men who are not using reliable contraception (methods used to prevent pregnancy).
Having an acute lung infection (a sudden, serious infection in the lungs) or severely reduced lung function (your lungs are not able to move air effectively).
Having bleomycin-related lung toxicity, which is damage to the lungs caused by the medicine bleomycin, or having reduced lung function that suggests this damage may be happening.
Having ataxia telangiectasia, which is a rare genetic disorder that affects the body's ability to coordinate movement and causes small, widened blood vessels to appear on the skin or eyes.

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Verified sites

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University Medical Center Ljubljana
Ljubljana, Slovenia

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Investigated drugs

Bleomycin is an injectable medication used in this study as a form of sclerotherapy. Its role is to be injected directly into low-flow vascular malformations to help shrink or close off the abnormal blood vessels.

Bleomycin Sulfate Ph. Eur.

What is already known about the treatment

Bleomycin sulfate - This medication is administered as a solution through an injection directly into the affected area. It is an established drug used in medicine, primarily known for its ability to treat certain types of cancer and now being studied for treating vascular malformations. As a chemotherapy agent, it works by causing breaks in the DNA strands within cells, which prevents them from growing or multiplying. This process helps to shrink or close off abnormal blood vessel growths during a procedure called electrosclerotherapy.

Investigated diseases

Vascular malformation - This condition occurs when blood vessels do not develop properly during fetal growth. These abnormal vessels can be located in the skin, connective tissue, or internal organs. In low-flow malformations, the blood moves through the affected area at a slower rate than normal. The condition can involve various types of vessels, such as veins or lymphatic channels. Over time, the malformation may cause visible swelling or changes in the texture of the affected area.