Bleomycin Electrosclerotherapy (BEST) for Slow-flow Vascular Malformations

NCT07720570 | Enrolling By Invitation

• 1 other identifier: p-2026-21479
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Slow-flow vascular malformations consist of abnormally formed veins, capillaries, lymphatic vessels, or a combination of these. They can cause pain, swelling, functional limitations, and concerns about appearance and may substantially affect quality of life. Bleomycin electrosclerotherapy (BEST) is an emerging treatment in which the sclerosant bleomycin is injected into the malformation and brief electrical pulses are applied to increase its local effect. As treatment of slow-flow vascular malformations primarily aims to alleviate symptoms and improve quality of life, patient-reported outcomes are central to assessing treatment benefit. However, the available evidence on patient-reported outcomes following BEST is sparse and heterogeneous, and prospective data are particularly limited. This prospective observational study follows children and adults undergoing BEST as part of routine clinical care at Copenhagen University Hospital - Rigshospitalet. The OVAMA questionnaire will be used to assess symptoms and appearance in all participants before treatment and at the 6-month follow-up. Depending on age, additional patient-reported measures will assess health-related quality of life (PROMIS-29) and pain (VAS) during follow-up. For adults, the study will assess changes in lesion size by comparing magnetic resonance imaging (MRI) scans performed before treatment and at 6 months. Adverse events will be recorded throughout follow-up. The study aims to evaluate whether patient-reported outcomes improve during the 6 months after BEST and to provide further information about treatment safety.

Conditions

Vascular Malformations

Keywords

Bleomycin electrosclerotherapy; Electroporation; Sclerotherapy; Patient-reported outcome measures; Slow-flow vascular malformations; Vascular malformations

Outcome Measures

Primary Outcomes (1)

• Change from baseline in OVAMA (Outcome Measures for Vascular Malformations) questionnaire scale scores

  The OVAMA questionnaire is a condition-specific patient-reported outcome measure assessing symptoms and appearance related to vascular malformations.

  Baseline and 6 months after BEST

Secondary Outcomes (4)

• Change from baseline in PROMIS-29 (Patient-Reported Outcomes Measurement Information System) domain scores

  Baseline and 6 months after BEST

• Pain intensity measured using a visual analogue scale (VAS)

  Baseline, 2 weeks, 1 month, 3 months, and 6 months after BEST

• Change from baseline in vascular malformation size assessed by MRI

  Baseline and 6 months after BEST

• Number of participants with adverse events following BEST

  From the day of the BEST procedure to the 6-month follow-up

Interventions

Bleomycin electrosclerotherapy (BEST) PROCEDURE

Bleomycin electrosclerotherapy combines intralesional administration of bleomycin with local electroporation, which transiently increases cell membrane permeability and enhances intracellular drug uptake within the vascular malformation.

Also known as: BEST

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants are identified among children and adults with slow-flow vascular malformations assessed by the multidisciplinary vascular malformation team at Copenhagen University Hospital - Rigshospitalet.

You may qualify if:

• Scheduled to undergo BEST as part of routine clinical care
• Diagnosis of a slow-flow vascular malformation confirmed by contrast-enhanced MRI performed within 6 months before enrollment.

You may not qualify if:

• Invasive treatment of the vascular malformation within 6 months before enrollment, including surgery, sclerotherapy, or laser treatment.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University of Copenhagen: collaborator

Study Sites (1)

Copenhagen University Hospital - Rigshospitalet

Copenhagen, Capital Region of Denmark, 2100, Denmark

Location

Related Publications (1)

• Gehr J, Hindso L, Taudorf M, Eiberg JP, Frevert SC, Jensen RJ, Kaltoft M, Lonn LB, de la Motte LR, Strom M, Clausen C. Effectiveness and Safety of Bleomycin Electrosclerotherapy for Slow-Flow Vascular Malformations: A Systematic Review. Cardiovasc Intervent Radiol. 2026 Jun;49(6):1105-1116. doi: 10.1007/s00270-026-04441-3. Epub 2026 Apr 27.

  PMID: 42045624 BACKGROUND

MeSH Terms

Conditions

Vascular Malformations

Condition Hierarchy (Ancestors)

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

Study Officials

• Caroline Clausen, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)