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

NCT07579962 | Not Yet Recruiting Phase 2

• 2 other identifiers: ORI2025-462025-524123-45-00
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vascular Malformations

Keywords

vascular malformations; electroporation; bleomycin; electrosclerotherapy; low flow vascular malformations

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 3 months after treatment

Secondary Outcomes (4)

• MRI-measured mean change in lesion volume from baseline to 12 months after BEST treatment

  Baseline and 12 months after treatment

• Number of participants who complete protocol-defined BEST treatment and follow-up visits

  Up to 12 months after treatment

• Number of participants with treatment-emergent adverse events as assessed by CTCAE version 5.0

  Up to 12 months after treatment

• Change in quality of life from baseline to 3 and 12 months after BEST treatment as assessed by the OVAMA questionnaire

  Baseline, 3 months, and 12 months after treatment

Study Arms (1)

Bleomycin electrosclerotherapy

EXPERIMENTAL

Participants with low-flow vascular malformations will receive intralesional bleomycin combined with local application of electrical pulses according to the BEST procedure.

Drug: Bleomycin Sulfate

Interventions

Bleomycin Sulfate DRUG

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

Also known as: Bleomycin Electrosclerotherapy

Bleomycin electrosclerotherapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead
• University Medical Centre Ljubljana: collaborator

MeSH Terms

Conditions

Vascular Malformations

Interventions

Bleomycin

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Gregor Serša

  Institute of Oncology Ljubljana

  STUDY CHAIR

Central Study Contacts

Neža Gros

CONTACT

031860131; ngros@onko-i.si

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2032
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share