Not Yet RecruitingPhase 2

Treatment of Low-flow Vascular Malformations With Bleomycin Electrosclerotherapy (BEST)

140 participantsStarted 2026-06-30

Plain-language summary

In biomedical applications, electroporation is used not only for cancer treatment but also for vaccinations, treatment of cardiac arrhythmias and, more recently, for the treatment of vascular malformations. Bleomycin is a frequently used sclerosing agent in the treatment of various vascular malformations. The use of electrical pulses in addition to bleomycin increases the effectiveness of the treatment, similar to electrochemotherapy. Bleomycin electrosclerotherapy (BEST) is a new treatment modality that is effective in the treatment of low-flow malformations (venous and lymphatic malformations) and potentially also high-flow malformations (arteriovenous malformations). Although a limited number of reports have been published to date, more and more centers are using BEST for the treatment of vascular malformations. As part of the International Network for Sharing Practices on Electrochemotherapy (InspECT) consortium, a dedicated working group has been set up to develop standard operating procedures for BEST. Current Operating Procedures have been prepared and will be used in this clinical trial.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age ≥ 18 * patients with low-flow vascular malformations (venous, lymphatic, capillary or mixed type malformations), * patients with a low-flow vascular malformation poorly responding or recurring after previous treatment(s), * longer lesion diameter not exceeding 25 cm. * more than one lesion can be treated. The limiting factor is the maximal dose per patient per treatment session; 10 000 IU in adults, * skin or mucosal, superficial or deep-seated lesions can be treated, * technical feasibility of the BEST procedure, i.e.: injection of bleomycin and safe placement of electrodes into the vascular malformation are technically feasible. Exclusion Criteria: * pregnancy and lactation, * women of childbearing potential and men not using reliable contraception, * in adults, previous bleomycin exposure with a cumulative dose greater than 100 000 IU. In case of abnormal respiratory results/chest pathology (including previous severe or long COVID) in consultation with a pulmonologist, special care is required, and bleomycin exposure may be contraindicated, * known allergy or hypersensitivity to bleomycin, * presence of significant central venous drainage precluding sclerotherapy, * acute lung infection or severely reduced lung function, * bleomycin-related lung toxicity or reduced lung function which can indicate bleomycin-related lung toxicity, * ataxia telangiectasia, * chronic renal dysfunction.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

MRI-measured mean change in lesion volume from baseline to 3 months after BEST treatment

Timeframe: Baseline and 3 months after treatment

Trial details

NCT IDNCT07579962

SponsorInstitute of Oncology Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-06-30

Contact for this trial

Neža Gros

031860131 ngros@onko-i.si

View on ClinicalTrials.gov More Vascular Malformations trials