[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548446":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":33,"responsibleParty":50,"collaborators":38,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":38,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":38,"maxAge":60,"enrollmentInfo":61,"targetDuration":38,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":36,"whyStopped":38,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Great Ormond Street Hospital for Children NHS Foundation Trust","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Micro-dosing Indocyanine Green (ICG)","EXPERIMENTAL","Multiple dose levels of intravenous Indocyanine Green (ICG) administered intra-operatively. Starting dose will be 10% of standard (for the study institution) and escalated as per protocol.",[13],"Drug: Indocyanine Green (ICG)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Indocyanine Green (ICG)","Cohorts will receive 0.01 mg\u002Fkg, 0.02 mg\u002Fkg, 0.04mg\u002Fkg, 0.06 mg\u002Fkg, or 0.08 mg\u002Fkg intra-venous ICG at surgery. Patients will be consecutively allocated to different doses as per protocol.",[9],[21],"Verdye by DiagnosticGreen",[23],{"name":24,"affiliation":25,"role":26},"Stefano Giuliani","Great Ormond Street Hospital","PRINCIPAL_INVESTIGATOR",[28],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","02074059200","0669","stefano.giuliani@gosh.nhs.uk",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Great Ormond Street Hospital for Children","RECRUITING","London",null,"WC1N 3JH","United Kingdom","UK",{"type":43,"coordinates":44},"Point",[45,46],-0.12574,51.50853,{"lat":46,"lon":45},[49],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},{"type":51,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100548446","micro-dosing-indocyanine-green-icg-in-children-100548446",false,"NCT06421103","Micro-dosing Indocyanine Green (ICG) in Children","Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children.","Inclusion Criteria:\n\n* Children aged ≤18 years of age\n* Elective surgery including gastrointestinal or genitourinary tract perfusion assessment\n\nExclusion Criteria:\n\n* Renal and liver dysfunction\n* Active infection\n* Coagulopathy\n* Complex congenital heart defect\n* Previous documented allergy to ICG injection or other iodinated contrast agents\n* Patients suffering from hyperthyroidism or autonomic thyroid adenomas\n* Premature infants or neonates in whom exchange transfusion is indicated, due to the hyperbilirubinaemia risk\n* Concurrent use of sodium bisulphite-containing preparations, such as certain heparin preparations","ALL","18 Years",{"count":62,"type":63},90,"ESTIMATED","INTERVENTIONAL",[66],"NA","The goal of this cohort study is to identify the lowest dose of Indocyanine Green (ICG) that achieves satisfactory intra-operative fluorescence for the assessment of gastrointestinal or genitourinary tract perfusion in children.",[69,70,71,72],"Perfusion","Fluorescence Imaging","Gastrointestinal Tract Disorders","Genitourinary Disease",[74,75,76,77,78,79,80],"Paediatric Surgery","Pediatric Surgery","Fluorescence","Imaging","Fluorescence Guided Surgery (FGS)","Intra-operative perfusion assessment","Indocyanine Green","2024-05-15",{"date":83,"type":84},"2024-05-20","ACTUAL",{"date":86,"type":63},"2024-06",{"date":88,"type":63},"2028-08",{"name":5,"class":6},1]