IRCT20240112060688N1 IRCT 2024-12-23 Shiraz University of Medical Sciences Everolimus in sub ependymal giant cell astrocytoma Efficacy of Everolimus in pediatric patients with tuberous sclerosis and sub ependymal giant cell astrocytoma 2024-12-21 anticipated 29 Complete https://irct.ir/trial/74986 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 4 tuberous sclerosis. Intervention group: eligible children (aged under ۱۸ years old) with a definite diagnosis of tuberous sclerosis complex will be included by convenience sampling method based on the inclusion exclusion criteria: Everolimus will be administered orally at a starting dose of ۴.۵ mg/m۲ body surface area per day for ۱۲ months duration and adjusted to attain blood trough concentrations of ۵-۱۵ ng/mL considering toxic side effects. All patients were monitored for adverse effects during everolimus treatment, like stomatitis, aphthous ulcer, flushing, hypertension, peripheral edema, hyperglycemia, abdominal pain and others included in questionnaire. In some patients because of unavailability of test for everolimus level we decreased ۲۰% of prescription dose after severe aphthous lesions or severe toxicity occurred. if patients do not tolerate everolimus, drug stopped and excluded from the study. Our patients followed for minimum one year after start of everolimus. Brain MRI will be done every ۳ months after initiation of the treatment and abdominal and pelvic sonography for angiomyolipima lesions in and reported in single specialized center and reported by a single expert radiologist. All patients will be completed an EEG at baseline and ۲۴ weeks (or end of treatment for those who discontinued) .Skin lesions will be assessed every ۳ months by physician in clinic according to size, number, color and location. Blood will be drawn every visit starting at week ۲ for everolimus drug level, including hematology and blood chemistry, will be done every ۲ weeks for the first ۴ weeks, then monthly.. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: starting after publication To whom: people working in academic institutions Conditions: no any other criteria Where to obtain: email How to obtain: email Comments: