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Completed

NCT Number: NCT07728825

Intralesional Bleomycin Sclerotherapy for Low-Flow Vascular Malformations of the Head and Neck

This study evaluated lesion volume reduction after intralesional bleomycin sclerotherapy in patients with low-flow vascular malformations of the head and neck, and identified predictors of treatment response. Twenty patients were enrolled across three Iraqi teaching hospitals and treated with intralesional bleomycin. Lesion volume was assessed by ultrasound or MRI at baseline and four weeks after the final treatment session.

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Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Al-Fallujah Teaching Hospital, Fallujah, Al-Anbar Governorate, Iraq

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About this study

Patients with clinically and radiologically confirmed low-flow vascular malformations of the head and neck were enrolled consecutively. Bleomycin was diluted to 3 mg/mL and injected intralesionally at multiple points, with a maximum of 15 mg per session and up to four sessions at three- to four-week intervals. Needle selection was guided by lesion depth, with ultrasound guidance used for deeper lesions. Lesion dimensions (length, width, depth) were measured by a single trained operator at each site; volume was calculated using the prolate ellipsoid formula (pi/6 x L x W x D), or by MRI-based volumetric segmentation for irregular multilocular lesions. Clinical response was graded using the modified Achauer scale. Adverse events were graded using CTCAE version 5.0, and peripheral oxygen saturation was monitored during and after each procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age older than one year
  • Clinically and radiologically confirmed low-flow vascular malformation of the head and neck
  • No prior bleomycin therapy
  • Medically fit for outpatient intervention

Exclusion criteria

  • High-flow vascular malformation
  • Pregnancy or lactation
  • Documented hypersensitivity to bleomycin
  • Pre-existing pulmonary or hepatic disease
  • Bleeding disorder or current anticoagulant use
  • Renal impairment (serum creatinine > 1.5 mg/dL or estimated glomerular filtration rate < 60 mL/min/1.73 m²)
  • Active infection at or near the treatment site

Treatment and study plan

Bleomycin (Bleocel 15)

Drug

Intralesional injection of bleomycin diluted with normal saline to 3 mg/mL. Maximum 15 mg per session; up to four sessions at three- to four-week intervals; cumulative dose capped at 400 mg. Administered under local anaesthesia or conscious sedation, with ultrasound guidance for deep lesions.

Primary outcomes

  1. Percentage reduction in lesion volume

    Time frame: Baseline to 4 weeks after the final treatment session

    Lesion volume derived from three orthogonal dimensions using the prolate ellipsoid formula (pi/6 x length x width x depth) on ultrasound or MRI, or by MRI volumetric segmentation for irregular lesions. Percentage reduction calculated relative to baseline volume.

Secondary outcomes

  1. Incidence and severity of adverse events

    Time frame: From the first treatment session through 4 weeks after the final treatment session, up to 16 weeks

    Adverse events documented and graded using CTCAE version 5.0, including monitoring of peripheral oxygen saturation for pulmonary safety

Sponsors and collaborators

Lead sponsor

University Of Anbar

Other

Registry information

Official study title

Evaluation of the Efficacy of Intralesional Bleomycin Injections for the Treatment of Low-Flow Vascular Malformations: A Multi-Center Study in Iraq

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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