[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617224":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":30,"studyPopulation":22,"armGroups":31,"interventions":38,"overallOfficials":22,"centralContacts":44,"locations":50,"responsibleParty":67,"collaborators":22,"id":71,"slug":22,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":22,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":53,"whyStopped":22,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"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 TGCT 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. Values will be compared between Diffuse-type TGCT (D-TGCT) and Localized-type TGCT (L-TGCT) cohorts.","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","Tenosynovial Giant Cell Tumor (TGCT), especially the diffuse type, poses a significant surgical challenge due to its infiltrative growth and high recurrence rate. This prospective, single-center, single-arm study aims to evaluate the accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing TGCT lesions during surgery. Eligible patients will receive an intravenous injection of ICG (0.25-0.5 mg\u002Fkg) 1-3 hours before surgery. Following standard tumor resection under white light, the surgical bed will be systematically explored using a near-infrared fluorescence imaging system to visualize potential tumor tissues. The surgeon will obtain validation samples from both fluorescence-positive areas and fluorescence-negative background tissues 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 resection, the surgical bed is systematically explored using a near-infrared fluorescence imaging system. The intervention consists of detecting residual fluorescence signals, obtaining verification samples for pathology, and performing supplementary resection of confirmed suspicious lesions to achieve potentially cleaner surgical margins.",[37],"Drug: Indocyanine Green",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":22},"DRUG","Indocyanine Green","Participants receive an intravenous injection of Indocyanine Green (ICG) at a dose of 0.25-0.5 mg\u002Fkg, 1-3 hours prior to surgery. Intraoperatively, a near-infrared fluorescence imaging system is used to guide the exploration. The intervention involves a \"verify first, treat later\" protocol: it includes diagnostic verification sampling of fluorescence-positive areas and, crucially, therapeutic supplementary resection of residual fluorescent lesions that were missed during standard white-light surgery.",[33],[45],{"name":46,"role":47,"phone":48,"phoneExt":22,"email":49},"Qingcheng Yang, Prof.","CONTACT","+86 21 6431 9181","tjyqc@163.com",[51],{"facility":52,"status":53,"city":54,"state":22,"zip":22,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Shanghai Sixth People's Hospital","RECRUITING","Shanghai","China","CN",{"type":58,"coordinates":59},"Point",[60,61],121.45806,31.22222,{"lat":61,"lon":60},[64],{"name":65,"role":47,"phone":66,"phoneExt":22,"email":49},"Qingcheng Yang, Doctor","021-64369181",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Qingcheng Yang","Chief Orthopaedic Surgeon & Director","100617224",false,"NCT07315841","Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Tenosynovial Giant Cell Tumor Surgery","A Prospective Study Evaluating the Accuracy of Indocyanine Green Fluorescence Imaging in Detecting Lesions During Tenosynovial Giant Cell Tumor Surgery","ICG-TGCT","Inclusion Criteria:\n\n* Diagnosed with Tenosynovial Giant Cell Tumor (TGCT), including both Localized-type (L-TGCT) and Diffuse-type (D-TGCT), 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":82,"type":83},40,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","This study evaluates the diagnostic accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing Tenosynovial Giant Cell Tumor (TGCT) lesions during surgery. Patients diagnosed with TGCT 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 and potential residual lesions in the surgical bed. 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 resected tissues.",[89],"Tenosynovial Giant Cell Tumor",[41,91,92,89],"Fluorescence Imaging","Near-Infrared Imaging","2026-01-02",{"date":95,"type":96},"2026-01-05","ACTUAL",{"date":93,"type":96},{"date":99,"type":83},"2026-12",{"name":5,"class":6},1]