Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT02509468
Eligibility Criteria:
* Patients aged from 6 years to 18 years
* With a slow-flow vascular malformation confirmed by MRI, included or not into a genetic disorder, among the following:
* microcystic lymphatic malformation
* mixed micro- and macrocystic malformation
* venous malformation
* combined lymphatic and venous malformation
* Malformation voluminous and complicated (pain, functional impairment, bleeding, seepage)
* Extended to the underlying subcutaneous tissue, to the fascias, the muscles and/or the underlying bone
* MRI of the VM performed within 8 months
* Vaccination schedule updated
* Informed, written consent of the subject's parents or the 18 years old subject
* Cooperative parent or subject, aware of the necessity and duration of controls so that perfect adhesion to the protocol could be expected
* Subjects or subject's parents covered by or having the rights to social security.
Exclusion criteria:
* Slow-flow VMs which are only macrocystic lymphatic malformations
* Visceral life-threatening involvement
* Patients who received prior per os treatment with an mTOR inhibitor
* Immunosuppression (immunosuppressive disease or immunosuppressive treatment)
* Known chronic infectious disease
* History of cancer in the 2 previous years
* Brest feeding or pregnant women, or women on childbearing age without effective contraception, up to 12 weeks after treatment discontinuation
* Known allergy to mTOR inhibitor
* Concomitant treatment that inhibits or activates CYP3A4, and P-gp glycoprotein, cytotoxic drugs, antilymphocyte immunoglobulines and metoclopramide
* Intolerance to fructose, intolerance or malabsorption to glucose, galactose, metabolic insufficiency in sucraseisomaltase, metabolic defect in lactase
* Known allergy to peanuts or soyabean
* Liver insufficiency (elevated transaminases \> 2.5 N)
* Anemia with Hb \< 9 g/dl
* Leukopenia \< 1000/mm3
* Thrombocytopenia \< 80 000/mm3
* Hypercholesterolemia (LDL-cholesterol ≥ 2g/l)
* Patients with risk of opportunistic infections
* Contraindication of MRI
* Known allergy to lidocaïne
* Live attenuated vaccine up to 3 months after sirolimus discontinuation
* Subject already participating to a therapeutic study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT02509468
Study Brief:
Protocol Section:
NCT02509468