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

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

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.

Study Overview

• Status: Completed
• Conditions: Vascular Malformations; Lymphatic Malformation; Venous Malformation
• Intervention / Treatment: Drug: Bleomycin (Bleocel 15)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iraq
  • Al-Anbar Governorate
    • Fallujah, Al-Anbar Governorate, Iraq, 54001
      • Al-Fallujah Teaching Hospital
  • Najaf
    • Najaf, Najaf, Iraq, 54001
      • Al-Najaf Al-Ashraf Teaching Hospital
    • Najaf, Najaf, Iraq, 54001
      • Al-Sadr Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intralesional bleomycin sclerotherapy; All participants received intralesional bleomycin sclerotherapy.	Drug: Bleomycin (Bleocel 15); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage reduction in lesion volume	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.	Baseline to 4 weeks after the final treatment session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events	Adverse events documented and graded using CTCAE version 5.0, including monitoring of peripheral oxygen saturation for pulmonary safety	From the first treatment session through 4 weeks after the final treatment session, up to 16 weeks

Collaborators and Investigators

• Sponsor: University Of Anbar

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2025
• Primary Completion (Actual): April 16, 2026
• Study Completion (Actual): April 26, 2026

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 23, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Sclerotherapy; Head and Neck; Bleomycin; Iraq
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Lymphatic Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Vascular Malformations; Lymphatic Abnormalities; Peptides; Amino Acids, Peptides, and Proteins; Carbohydrates; Glycoconjugates; Glycopeptides; Bleomycin
• Other Study ID Numbers: UOA-COD-OMFS-173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No