Bleomycin sulfate for Vascular malformation

Inclusion criteria

• {"criterion_text":"-Patients with low-flow vascular malformations (venous, lymphatic, capillary or mixed type malformations),"}
• {"criterion_text":"-Patients with a low-flow vascular malformation poorly responding or recurring after previous treatment(s)."}
• {"criterion_text":"-Technical feasibility of the BEST procedure, i.e.: injection of bleomycin and safe placement of electrodes into the vascular malformation are technically feasible."}
• {"criterion_text":"-age ≥ 18"}
• {"criterion_text":"-longer lesion diameter not exceeding 25 cm."}
• {"criterion_text":"-more than one lesion can be treated. The limiting factor is the maximal dose per patient per treatment session; 10 000 IU in adults,"}
• {"criterion_text":"-skin or mucosal, superficial or deep-seated lesions can be treted,"}

Exclusion criteria

• {"criterion_text":"-Pregnancy and lactation"}
• {"criterion_text":"-chronic renal dysfunction."}
• {"criterion_text":"-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,"}
• {"criterion_text":"-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."}
• {"criterion_text":"-Known allergy or hypersensitivity to bleomycin."}
• {"criterion_text":"-Presence of significant central venous drainage precluding sclerotherapy."}
• {"criterion_text":"-women of childbearing potential and men not using reliable contraceptive,"}
• {"criterion_text":"-acute lung infection or severely reduced lung function,"}
• {"criterion_text":"-bleomycin-related lung toxicity or reduced lung function which can indicate bleomycin-related lung toxicity,"}
• {"criterion_text":"-ataxia telangiectasia,"}

Primary endpoints

• {"endpoint_text":"-To evaluate effectiveness of BEST in reducing lesion volume, as measured by MRI 3 months after the treatment in patients with low-flow vascular malformations.","definition_or_measurement_approach":"Lesion volume reduction measured by MRI at 3 months post-treatment."}

Secondary endpoints

• {"endpoint_text":"-Assessment of the effectiveness of BEST 12 months after the treatment.","definition_or_measurement_approach":"Effectiveness assessed at 12 months after treatment (no further measurement detail provided)."}
• {"endpoint_text":"-Feasibility of recruitment and treatment according to the Current Operating Procedures","definition_or_measurement_approach":"Feasibility assessed according to adherence to Current Operating Procedures (no further measurement detail provided)."}
• {"endpoint_text":"-Safety and tolerability: Incidence, severity and relationship of treatment-emergent adverse events classified accordint to MedDRA and graded using CTCEA v5.0","definition_or_measurement_approach":"Adverse events classified using MedDRA and graded using CTCEA v5.0 (as stated)."}
• {"endpoint_text":"-Quality of life: QoL assessment with clinically validated OVAMA questioner.","definition_or_measurement_approach":"Quality of life measured using the clinically validated OVAMA questionnaire."}

Slovenia

Earliest CTIS Part Ii Submission Date

02-04-2026

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

5

Number Of Sites

1

Number Of Participants

140

Primary sponsor

Full Name

Institute Of Oncology Ljubljana

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Slovenia