NCT07579962 Treatment of Low-flow Vascular Malformations With Bleomycin Electrosclerotherapy (BEST)
| NCT ID | NCT07579962 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Oncology Ljubljana |
| Condition | Vascular Malformations |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-09-10 |
| Primary Completion | 2031-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2026-09-10 with a primary completion date of 2031-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Gregor Serša
STUDY CHAIR
Institute of Oncology Ljubljana
Frequently Asked Questions
Who can join the NCT07579962 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Vascular Malformations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07579962 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07579962 currently recruiting?
Yes, NCT07579962 is actively recruiting participants. Contact the research team at ngros@onko-i.si for enrollment information.
Where is the NCT07579962 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT07579962 clinical trial?
NCT07579962 is sponsored by Institute of Oncology Ljubljana. The principal investigator is Gregor Serša at Institute of Oncology Ljubljana. The trial plans to enroll 140 participants.