Systematic treatment approach for children with orbital lymphatic malformation using sirolimus
Official title: Systematic Management Approach for Children and Adolescents With Orbital Lymphatic Malformation
Run by Ain Shams University · NCT07378657 · Data updated 2026-11-12
This will test whether sirolimus, given alone or with injection sclerotherapy, is safe and helps children and teens (ages 1–18) with orbital lymphatic malformation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | November 1, 2027 |
| Study ends | November 1, 2027 |
| Registry record updated | January 30, 2026 |
| Trial ID | NCT07378657 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents aged 1–18 with imaging-confirmed low‑flow orbital lymphatic malformation who are symptomatic or have progressive disease are the intended candidates.
✕Probably not a fit
Patients with high‑flow vascular malformations, adults outside the age range, or those with contraindications to sirolimus or bleomycin are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional program at Ain Shams University groups children and adolescents (1–18 years) with low‑flow orbital lymphatic malformation by cyst size, anatomic extension, vascular components, and symptoms. Symptomatic patients without complex disease are assigned to intralesional sclerotherapy (bleomycin 0.6 mg/kg), patients with complex or progressive disease receive oral sirolimus (0.8 mg/m2 twice daily for 6 months), and some receive both local and systemic therapy. The protocol tracks safety and efficacy through changes in lesion size, symptom control, and the need for further procedures. Participants undergo clinical and radiologic follow-up and laboratory monitoring for sirolimus toxicity at the single Cairo center.
Why it matters
Potential benefit: If successful, this approach could reduce lesion size and symptoms and offer a standardized, less invasive treatment pathway for children with orbital lymphatic malformation.
How similar studies have gone: Prior case series and smaller studies of sirolimus for lymphatic and other vascular malformations have reported lesion shrinkage and symptom improvement, though large randomized data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Age : 1-18 years Children and adolescents diagnosed with orbital low flow vascular malformation based on clinical , radilogical findings Exclusion Criteria: Children and adolescents with orbital high flow vascular malformation
Where it's running
-
Ain Shams University
Cairo, Cairo Governorate, Egypt Recruiting
Study contacts
- Study coordinator: nihal hussien aly mostafa
- Email: nihal.hussien.ali@gmail.com
- Phone: +201001053961
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.