RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Institute of Oncology Ljubljana • ClinicalTrials.gov ID: NCT07579962

Registry updated: 2026-10-09

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Description

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.

Interventions

Bleomycin Sulfate (Drug)
Bleomycin will be administered by local intralesional injection into the vascular malformation, followed by application of electrical pulses.

Eligibility criteria

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.

Conditions

Vascular Malformations

Locations

Institute of Oncology Ljubljana — Ljubljana, Slovenia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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