Bleomycin Electrosclerotherapy for Low-Flow Vascular Malformations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional study investigates bleomycin electrosclerotherapy (BEST) for low-flow vascular malformations such as venous and lymphatic lesions. Bleomycin is delivered directly into the malformed vessels, and brief electrical pulses are applied to enhance drug uptake and efficacy. Eligible adults with one or more low-flow malformations that have not fully responded to prior treatment may receive this combined therapy. The trial aims to determine safety, tolerability, and preliminary effectiveness of BEST in reducing lesion size and symptoms. The study is conducted under the InspECT collaboration and follows standard operating procedures for electrochemotherapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Oncology Ljubljana
  Ljubljana, Slovenia Recruiting

Study contacts

• Study coordinator: Neža Gros
• Email: ngros@onko-i.si
• Phone: 031860131

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment for low-flow venous malformations using electrosclerotherapy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.