[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617223":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":30,"studyPopulation":22,"armGroups":31,"interventions":38,"overallOfficials":22,"centralContacts":46,"locations":52,"responsibleParty":69,"collaborators":22,"id":73,"slug":22,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":22,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":55,"whyStopped":22,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Shanghai Jiao Tong University Affiliated Sixth People's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic Accuracy of ICG Fluorescence Imaging (Sensitivity, Specificity, PPV, NPV)","The diagnostic performance of ICG fluorescence imaging in detecting GCTB lesions will be evaluated by comparing the intraoperative fluorescence status (Positive\u002FNegative) with the final histopathological diagnosis (Tumor\u002FNon-tumor) of the resected specimens. The unit of analysis is the individual specimen. The following metrics will be calculated: Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV).","From the time of surgery until the final pathology report is available, assessed up to 1 week post-operatively.",[14,18],{"measure":15,"description":16,"timeFrame":17},"Tumor-to-Background Ratio (TBR)","TBR is a quantitative measure of fluorescence intensity. It will be calculated by dividing the mean fluorescence intensity of the tumor region by the mean fluorescence intensity of the adjacent normal background tissue using image analysis software.","Intraoperative",{"measure":19,"description":20,"timeFrame":21},"Incidence of ICG-Related Adverse Events","The number of participants experiencing adverse events related to ICG administration (e.g., allergic reactions, anaphylactic shock) will be monitored and recorded.","From the time of ICG injection through 24 hours post-surgery",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":22,"timePerspective":22,"maskingInfo":28},"NA","SINGLE_GROUP","This is a prospective, single-center, single-arm study.","DIAGNOSTIC",{"masking":29,"maskingDescription":22,"whoMasked":22},"NONE","Giant Cell Tumor of Bone (GCTB) poses a significant surgical challenge due to the difficulty in detecting microscopic residual tumor tissues in the bone cavity, which contributes to a high local recurrence rate. This prospective, single-center, single-arm study aims to evaluate the accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing GCTB lesions during surgery. Eligible patients will receive an intravenous injection of ICG (0.25-0.5 mg\u002Fkg) 1-6 hours before surgery. Following standard tumor curettage under white light, the bone cavity will be systematically explored using a near-infrared fluorescence imaging system to visualize potential residual tumor tissues. The surgeon will obtain validation samples from fluorescence-positive areas, fluorescence-negative background tissues, and post-treatment beds for blinded pathological assessment. The study will quantify the diagnostic performance of ICG imaging by calculating sensitivity, specificity, positive predictive value, and negative predictive value based on the pathological gold standard, alongside secondary analyses of tumor-to-background ratios and microscopic tumor boundary concordance.",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"ICG Fluorescence Imaging Group","EXPERIMENTAL","All enrolled participants receive ICG fluorescence-guided surgery. Following standard tumor curettage, the bone cavity is systematically explored using a near-infrared fluorescence imaging system. The intervention consists of detecting residual fluorescence signals, obtaining verification samples for blinded pathological assessment, and performing supplementary curettage of confirmed suspicious lesions to achieve potentially cleaner surgical margins.",[37],"Drug: Indocyanine Green",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","Indocyanine Green","Participants receive an intravenous injection of Indocyanine Green (ICG) at a dose of 0.25-0.5 mg\u002Fkg, 1-6 hours prior to surgery. Intraoperatively, a near-infrared fluorescence imaging system is used to guide the exploration of the bone cavity. The intervention involves a \"verify first, treat later\" protocol: it includes diagnostic verification sampling of fluorescence-positive areas and, crucially, therapeutic supplementary curettage of residual fluorescent lesions that were missed during standard white-light surgery.",[33],[45],"ICG",[47],{"name":48,"role":49,"phone":50,"phoneExt":22,"email":51},"Qingcheng Yang, Prof.","CONTACT","+86 21 6431 9181","tjyqc@163.com",[53],{"facility":54,"status":55,"city":56,"state":22,"zip":22,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Shanghai Sixth People's Hospital","RECRUITING","Shanghai","China","CN",{"type":60,"coordinates":61},"Point",[62,63],121.45806,31.22222,{"lat":63,"lon":62},[66],{"name":67,"role":49,"phone":68,"phoneExt":22,"email":51},"Qingcheng Yang, Doctor","021-64369181",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Qingcheng Yang","Chief Orthopaedic Surgeon & Director","100617223",false,"NCT07315828","Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Giant Cell Tumor of Bone Surgery","A Prospective Study on the Accuracy of Indocyanine Green Fluorescence Imaging for the Visualization of Residual Lesions in the Tumor Cavity During Surgery for Giant Cell Tumor of Bone","ICG-GCTB","Inclusion Criteria:\n\n* Diagnosed with Giant Cell Tumor of Bone(GCTB), via preoperative biopsy or typical imaging (MRI), and scheduled for surgical resection.\n* Capable of understanding the study and voluntarily signing the written informed consent form.\n\nExclusion Criteria:\n\n* Known severe history of allergy to Indocyanine Green (ICG) or iodine.\n* Severe liver dysfunction.\n* Women who are pregnant or lactating.","ALL","18 Years","75 Years",{"count":84,"type":85},40,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","This study evaluates the diagnostic accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing residual lesions of Giant Cell Tumor of Bone (GCTB) in the tumor cavity during surgery. Patients diagnosed with GCTB will receive an intravenous injection of ICG prior to the operation to label tumor tissues. During the procedure, surgeons will use a near-infrared fluorescence imaging system to visualize the tumor cavity and identify potential residual lesions after standard curettage. The study aims to determine the sensitivity, specificity, positive predictive value, and negative predictive value of ICG fluorescence imaging by comparing the intraoperative fluorescence findings with the final pathological results of the validation samples.",[91],"Giant Cell Tumor of Bone",[41,93,94,91],"Fluorescence Imaging","Near-Infrared Imaging","2026-01-02",{"date":97,"type":98},"2026-01-05","ACTUAL",{"date":95,"type":98},{"date":101,"type":85},"2026-12",{"name":5,"class":6},1]