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.
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.
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,
Single group
Bleomycin Sulfate
DrugBleomycin will be administered by local intralesional injection into the vascular malformation, followed by application of electrical pulses.
MRI-measured mean change in lesion volume from baseline to 3 months after BEST treatment
Lesion volume will be assessed by magnetic resonance imaging at baseline and 3 months after treatment. Lesion volume will be calculated from MRI images using the ellipsoid formula: a x b x c x π/6. The outcome measure will report the mean change in lesion volume from baseline to 3 months after BEST treatment.
MRI-measured mean change in lesion volume from baseline to 12 months after BEST treatment
Lesion volume will be assessed by magnetic resonance imaging at baseline and 12 months after treatment. Lesion volume will be calculated from MRI images using the ellipsoid formula: a x b x c x π/6. The outcome measure will report the mean change in lesion volume from baseline to 12 months after BEST treatment.
Number of participants who complete protocol-defined BEST treatment and follow-up visits
Feasibility will be assessed by the number of participants who complete the protocol-defined BEST treatment and scheduled follow-up visits at 3 months and 12 months after treatment.
Number of participants with treatment-emergent adverse events as assessed by CTCAE version 5.0
Treatment-emergent adverse events will be recorded, classified according to MedDRA terminology, graded using CTCAE version 5.0, and assessed for relationship to the investigational medicinal product or procedure.
Change in quality of life from baseline to 3 and 12 months after BEST treatment as assessed by the OVAMA questionnaire
Quality of life will be assessed using the OVAMA questionnaire at baseline, 3 months, and 12 months after treatment. The outcome measure will report the change in OVAMA questionnaire results from baseline to 3 and 12 months after BEST treatment.
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Institute of Oncology Ljubljana
Lead sponsor
University Medical Centre Ljubljana
Collaborator
