[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608249":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":29,"interventions":40,"overallOfficials":17,"centralContacts":45,"locations":51,"responsibleParty":272,"collaborators":17,"id":274,"slug":17,"hasResults":275,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":17,"eligibilityCriteria":279,"healthyVolunteers":275,"sex":280,"minAge":281,"maxAge":282,"enrollmentInfo":283,"targetDuration":17,"studyType":286,"phases":287,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":296,"whyStopped":17,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},{"fullName":5,"class":6},"Beijing Children's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"To evaluate the diagnostic performance of CT findings, including the concordance rate with pathological gold standards, other imaging modalities (e.g., MRI), or clinical diagnoses.","With the clinical diagnosis (finally confirmed in pediatric patients after consultation, based on pathology, laboratory tests, other imaging examinations, and clinical characteristics) as the gold standard, determine the concordance rate between CT findings and clinical diagnoses.","From enrollment to the end of treatment at 12 weeks",[14],{"measure":15,"description":16,"timeFrame":12},"To assess discrepancies in subjective image quality ratings among observers, using the Multi-Rater Concordance Correlation (MCRC) statistical method to evaluate the consistency of ratings across different observers.","To analyze differences in diagnostic confidence in images among observers with different years of experience. For CT diagnostic reports showing insufficient diagnostic confidence, the specific criterion is the frequency of descriptive terms indicating low confidence (e.g., \"possible,\" \"further examination required,\" \"follow-up review recommended\") in the reports.\n\nTo compare differences in radiation doses (CTDI in mSv) between two CT protocols with different dose settings.\n\nTo calculate the radiation dose (CTDI in mSv) difference between the two protocols based on radiation dose data from dose reports.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","On the RCT trial procedure, Participants will be randomly assigned to the intervention group (adopting the pediatric low-dose CT protocol established based on LDS) or the conventional CT dose group (adopting China's pediatric CT Diagnostic Reference Level protocol) at a 1:1 ratio. A statistician who is not directly involved in the analysis of study results or image evaluation will develop independent randomization schemes for each participating center using the randomized block design, so as to further reduce inter-center bias and ensure the concealment of the allocation scheme.","DIAGNOSTIC",{"masking":24,"maskingDescription":17,"whoMasked":25},"TRIPLE",[26,27,28],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR",[30,34],{"label":31,"type":32,"description":33,"interventionNames":17},"Routine dose CT","NO_INTERVENTION","Participants will undergo a routine dose CT adopting China's pediatric CT Diagnostic Reference Level protocol",{"label":35,"type":36,"description":37,"interventionNames":38},"Low dose CT","EXPERIMENTAL","Participants will undergo a low dose CT adopting the pediatric low-dose CT protocol established based on LDS",[39],"Radiation: Low dose CT",[41],{"type":42,"name":35,"description":43,"armGroupLabels":44,"otherNames":17},"RADIATION","Participants will undergo a low dose CT adopting the pediatric low-dose CT protocol established based on low dose simulation technique.",[35],[46],{"name":47,"role":48,"phone":49,"phoneExt":17,"email":50},"Jihang Sun, MD","CONTACT","+86 13521158011","jihangsuns@163.com",[52,66,76,86,91,96,106,120,134,144,158,172,182,196,205,215,229,243,253,258],{"facility":53,"status":17,"city":54,"state":55,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Beijing Children's Hospital, Capital Medical University, National Center for Children's Health","Beijing","Beijing Municipality","China","CN",{"type":59,"coordinates":60},"Point",[61,62],116.39723,39.9075,{"lat":62,"lon":61},[65],{"name":47,"role":48,"phone":49,"phoneExt":17,"email":50},{"facility":67,"status":17,"city":54,"state":55,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Beijing Friendship Hospital, Capital Medical University",{"type":59,"coordinates":69},[61,62],{"lat":62,"lon":61},[72],{"name":73,"role":48,"phone":74,"phoneExt":17,"email":75},"Yantao Niu, PhD","+86 13693664085","ytniu163@163.com",{"facility":77,"status":17,"city":54,"state":55,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Beijing Tongren Hospital, Capital Medical University",{"type":59,"coordinates":79},[61,62],{"lat":62,"lon":61},[82],{"name":83,"role":48,"phone":84,"phoneExt":17,"email":85},"Dandan Liu, PhD","+86 13701124170","trdandan4170@163.com",{"facility":87,"status":17,"city":54,"state":55,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":88,"geoPoint":90,"contacts":17},"Medical Center for Capital Children's Health, Capital Medical University",{"type":59,"coordinates":89},[61,62],{"lat":62,"lon":61},{"facility":92,"status":17,"city":54,"state":55,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":93,"geoPoint":95,"contacts":17},"National Institute for Radiological Protection, China CDC",{"type":59,"coordinates":94},[61,62],{"lat":62,"lon":61},{"facility":97,"status":17,"city":54,"state":55,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"Peking Union Medical College Hospital",{"type":59,"coordinates":99},[61,62],{"lat":62,"lon":61},[102],{"name":103,"role":48,"phone":104,"phoneExt":17,"email":105},"Wei Liu, MD","+86 13261960902","lwpumch@163.com",{"facility":107,"status":17,"city":108,"state":109,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders.","Chongqing","Chongqing Municipality",{"type":59,"coordinates":111},[112,113],106.55771,29.56026,{"lat":113,"lon":112},[116],{"name":117,"role":48,"phone":118,"phoneExt":17,"email":119},"Ling He, MD","+86 13983399138","480056@hospital.cqmu.edu.cn",{"facility":121,"status":17,"city":122,"state":123,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Guangdong Women and Children Hospital","Guangzhou","Guangdong",{"type":59,"coordinates":125},[126,127],113.25,23.11667,{"lat":127,"lon":126},[130],{"name":131,"role":48,"phone":132,"phoneExt":17,"email":133},"Zhiqiu Ye, MD","+86 13688898540","ye0542@sina.cn",{"facility":135,"status":17,"city":122,"state":123,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":136,"geoPoint":138,"contacts":139},"Nanfang Hospital, Southern Medical University",{"type":59,"coordinates":137},[126,127],{"lat":127,"lon":126},[140],{"name":141,"role":48,"phone":142,"phoneExt":17,"email":143},"Ge Wen, MD","+86 13360022166","1113470826@qq.com",{"facility":145,"status":17,"city":146,"state":147,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Baoding Hospital, Beijing Children's Hospital Affiliated to Capital Medical University","Baoding","Heibei",{"type":59,"coordinates":149},[150,151],115.46246,38.87288,{"lat":151,"lon":150},[154],{"name":155,"role":48,"phone":156,"phoneExt":17,"email":157},"Lili Zang, MD","+86 15203220998","1374190373@qq.com",{"facility":159,"status":17,"city":160,"state":161,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Fuwai Central China Cardiovascular Hospital","Zhengzhou","Henan",{"type":59,"coordinates":163},[164,165],113.64861,34.75778,{"lat":165,"lon":164},[168],{"name":169,"role":48,"phone":170,"phoneExt":17,"email":171},"Yinghui Ge, MD","+86 13603989332","cjr.geyinghui@vip.163.com",{"facility":173,"status":17,"city":160,"state":161,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":174,"geoPoint":176,"contacts":177},"The Third Affiliated Hospital of Zhengzhou University",{"type":59,"coordinates":175},[164,165],{"lat":165,"lon":164},[178],{"name":179,"role":48,"phone":180,"phoneExt":17,"email":181},"Xin Zhao, MD","+86 13676939116","zdsfyzx@zzu.edu.cn",{"facility":183,"status":17,"city":184,"state":185,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Affiliated Women's Hospital of Jiangnan University","Wuxi","Jiangsu",{"type":59,"coordinates":187},[188,189],120.28857,31.56887,{"lat":189,"lon":188},[192],{"name":193,"role":48,"phone":194,"phoneExt":17,"email":195},"Xinkai Zhao, MD","+86 15861600014","zxk_kk@163.com",{"facility":197,"status":17,"city":198,"state":199,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":200,"geoPoint":204,"contacts":17},"Children's Hospital of Changchun","Changchun","Jilin",{"type":59,"coordinates":201},[202,203],125.32278,43.88,{"lat":203,"lon":202},{"facility":206,"status":17,"city":198,"state":199,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":207,"geoPoint":209,"contacts":210},"the First Hospital of Jilin University",{"type":59,"coordinates":208},[202,203],{"lat":203,"lon":202},[211],{"name":212,"role":48,"phone":213,"phoneExt":17,"email":214},"Jing Wang, MD","+86 15804300153","wangj66@jlu.edu.cn",{"facility":216,"status":17,"city":217,"state":218,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"The First Affiliated Hospital of Xi'an Jiao Tong University","Xi'an","Shaanxi",{"type":59,"coordinates":220},[221,222],108.92861,34.25833,{"lat":222,"lon":221},[225],{"name":226,"role":48,"phone":227,"phoneExt":17,"email":228},"Jian Yang, MD","+86 18191975783","yj1118@mail.xjtu.edu.cn",{"facility":230,"status":17,"city":231,"state":232,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Shanghai Children's Medical Center, School of Medicine","Shanghai","Shanghai Municipality",{"type":59,"coordinates":234},[235,236],121.45806,31.22222,{"lat":236,"lon":235},[239],{"name":240,"role":48,"phone":241,"phoneExt":17,"email":242},"Yumin Zhong, MD","+86 18930830851","zyumin2002@163.com",{"facility":244,"status":17,"city":231,"state":232,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":245,"geoPoint":247,"contacts":248},"Shanghai Jiao Tong University School of Medicine",{"type":59,"coordinates":246},[235,236],{"lat":236,"lon":235},[249],{"name":250,"role":48,"phone":251,"phoneExt":17,"email":252},"Dengbin Wang, MD","+86 13916656531","dbwang8@aliyun.com",{"facility":254,"status":17,"city":231,"state":232,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":255,"geoPoint":257,"contacts":17},"ShanghaiTech University",{"type":59,"coordinates":256},[235,236],{"lat":236,"lon":235},{"facility":259,"status":17,"city":260,"state":261,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"People's Hospital of Xinjiang Uygur Autonomous Region","Ürümqi","Xinjiang",{"type":59,"coordinates":263},[264,265],87.60046,43.80096,{"lat":265,"lon":264},[268],{"name":269,"role":48,"phone":270,"phoneExt":17,"email":271},"Yan Wang, MD","+86 13699982055","drwangxj@163.com",{"type":273,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100608249",false,"NCT07199101","Multicenter Pediatric Low-Dose CT Protocol: Development and Clinical Verification","Development of a Multicenter Low-Dose CT Protocol for Children Based on Low-Dose Simulation Technology and Verification by Clinical Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 0-17 years.\n* Pediatric patients for whom a CT examination is deemed necessary by an attending physician.\n\nExclusion Criteria:\n\n* Parents\u002Fguardians refuse to consent to low-dose CT examination.\n* Pediatric patients are in critical condition, with no time allocated for explanation of the randomized controlled trial (RCT) protocol.","ALL","0 Years","18 Years",{"count":284,"type":285},2650,"ESTIMATED","INTERVENTIONAL",[288],"NA","Children are sensitive to ionizing radiation, and there are significant regional variations in current pediatric CT radiation doses. Although there are studies on low-dose CT targeting single lesions, these studies require clear clinical indications and support from advanced equipment, making widespread promotion difficult. The establishment of low-dose CT protocols is mostly experience-based; when radiologists lack confidence in image quality, the credibility of diagnostic reports is compromised. Therefore, the development of low-dose protocols must meet the diagnostic confidence of most radiologists, enable clear visualization of key anatomical structures in clinical practice, and satisfy the requirements for disease diagnosis.\n\nThe purpose of this study is to establish a pediatric low-dose CT scanning protocol using Low-dose Simulation of CT (LDS) technology, and conduct a multicenter randomized controlled trial (RCT) in clinical settings to verify the clinical feasibility of this low-dose CT scanning protocol.",[291],"Radiation Dose Reduction",[293,294,295],"Tomography, X-ray computed","Child","radiation dose","NOT_YET_RECRUITING","2025-09-22",{"date":299,"type":300},"2025-09-30","ACTUAL",{"date":302,"type":285},"2026-01-01",{"date":304,"type":285},"2027-12-31",{"name":5,"class":6},20]