[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100304425":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":66,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":11,"maxAge":81,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SIROLIMUS","EXPERIMENTAL",null,[13,14,15],"Drug: rapamycin","Device: MRI","Biological: Rapamycin dosage",[17,22,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"DRUG","rapamycin","oral administration",[9],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"DEVICE","MRI","cervicofacial MRI",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"BIOLOGICAL","Rapamycin dosage","Biological dosage of Rapamycin level",[9],[33],{"name":34,"affiliation":5,"role":35},"Pierre Fayoux, MD","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","3 20 44 50 67","+33","pierre.fayoux@chru-lille.fr",[43,58],{"facility":44,"status":45,"city":46,"state":11,"zip":11,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Hôpital Jeanne de Flandres, CHU","RECRUITING","Lille","France","FR",{"type":50,"coordinates":51},"Point",[52,53],3.05512,50.63391,{"lat":53,"lon":52},[56],{"name":57,"role":35,"phone":11,"phoneExt":11,"email":11},"pierre Fayoux, MD",{"facility":59,"status":45,"city":60,"state":11,"zip":11,"country":47,"countryCode":48,"cosmosGeoPoint":61,"geoPoint":65,"contacts":11},"Hu Robert Debre Aphp - Paris","Paris",{"type":50,"coordinates":62},[63,64],2.3488,48.85341,{"lat":64,"lon":63},{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[69],{"name":70,"class":71},"Ministry of Health, France","OTHER_GOV","100304425","phase-2-efficacy-of-rapamycin-in-the-treatment-of-cervico-facial-lymphatic-malformations-100304425",false,"NCT03243019","Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations","Evaluation of the Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations of Poor Prognosis","RAPAMALYMPH","Inclusion Criteria:\n\n* Patient from 0 to 18 years of age, presenting with poly-cystic suprahyoid or mediastinal lymphatic.\n* with chronic pain or functional respiratory or swallowing impairment with a CDS score \\\u003C 8\n* Curative treatment is not possible or associated with a high risk of morbidity ,mortality and functional and cosmetic impairment\n* Karnofsky Score (\\> 10 years of age) or Lansky score (≤10 years of age) \\> 50%\n* Biology\n\n  * Neutrophils count≥1.0 x 109\u002FL\n  * Platelets count ≥ 100 x 109\u002FL\n  * Hemoglobin ≥ 8 g\u002FdL\n  * Bilirubin ≤ 1,5 ULN\n  * Transaminases \\\u003C 2,5 ULN\n  * Serum albumin ≥ 2 g\u002FdL.\n  * LDL cholesterol \\\u003C160 mg\u002FdL\n  * Triglycerides \\\u003C 150 mg\u002FdL\n* Negative test of pregnancy if relevant\n* Social security affiliation\n* At least 2 months after a previous procedure on the malformation\n\nExclusion Criteria:\n\n* Non-respect of inclusion criteria\n* Other immunosuppressive therapy or long-term general corticosteroid therapy without a 28-day washout period\n* renal failure\n* Liver failure\n* Digestive disease leading to rapamycin malabsorption\n* uncontrolled or severe infectious disease\n* Patients requiring treatment interfering with CYP3A4 isoenzyme (rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin) or inhibiting CYP3A4 isoenzyme's activity (ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin, Diltiazem, Verapamil, nicardipine, clotrimazole, fluconazole , troleandomycin, bromocriptine, cimetidine, danazol, protease inhibitors) -patients requiring treatment by cisapride and metoclopramide\n* Concomitant administration of mTOR inhibitor\n* Peanuts or soya allergy\n* Impossibility to receive informed consent\n* Absence of social security affiliation\n* refusal to sign consent\n* Ongoing pregnancy or breastfeeding\n* refusal to participate","ALL","18 Years",{"count":83,"type":84},28,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","To evaluate the efficacy of Rapamycin in extended cervicofacial lymphatic malformations in pediatric patients. Rapamycin is administered oral for a 6 month period.\n\nThe success rate is determined by volume reduction superior to 1\u002F5e of the initial volume measured by MRI, impact on QOL and reduction of bleeding in case of mucosal involvement.",[90,91],"Lymphatic Malformation","Pediatric",[93,19],"cervico-facial","2026-05-20",{"date":96,"type":97},"2026-05-22","ACTUAL",{"date":99,"type":97},"2018-06-25",{"date":101,"type":84},"2027-02",{"name":5,"class":6},2]