Actively Recruiting
Systematic Approach for Children With Orbital Malformation With Sirolimus Use
Led by Ain Shams University · Updated on 2026-01-30
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this interventional study is to Set a systematic management approach for orbital lymphatic malformation and to study the safety and efficacy of sirolimus in children and adolescents with orbital lymphatic malformation\]. The main questions it aims to answer are: \[what is the safety of using sirolimus in patients with orbital lymphatic malformation\]? \[what is the efficacy of sirolimus in patients with orbital lymphatic malformation\]? Participants will be divided into three groups based on their symptoms, extent and type of orbital lymphatic malformation Group 1 ( will receive injection sclerotherapy): All Patients with symptomatic lymphatic malformation except those with complex malformation , Group 2 (will receive sirolimus on 0.8 mg per m2 twice daily for 6 months ):A) Patients with symptomatic complex lymphatic malformation. B) Patients in group 1 if there is progression in lesion size or ineffective local therapy Group 3 ( will receive both injection sclerotherapy and sirolimus):A) Patients in group 1 and patients with complex lymphatic malformation if there is concern for complications like hemorrhage, amblyopia and vision loss since diagnosis.
CONDITIONS
Official Title
Systematic Approach for Children With Orbital Malformation With Sirolimus Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 to 18 years
- Children and adolescents diagnosed with orbital low flow vascular malformation based on clinical and radiological findings
You will not qualify if you...
- Children and adolescents with orbital high flow vascular malformation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ain Shams University
Cairo, Cairo Governorate, Egypt, 11321
Actively Recruiting
Research Team
N
nihal hussien aly mostafa
CONTACT
I
iman ahmed ragab
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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