[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tenosynovial-giant-cell-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tenosynovial-giant-cell-tumor":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,72,101,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100631337","phase-2-study-of-pimicotinib-in-japanese-participants-with-tenosynovial-giant-cell-tumor-tgct-j-maneuver-100631337",false,"NCT07499362","Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)","Phase 2, Single-arm Study to Investigate the Tolerability, Pharmacokinetics, Efficacy, and Safety of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor","Inclusion Criteria:\n\n* Japanese participants with a diagnosis of TGCT that has been histologically confirmed at the local laboratory and is unresectable (that is \\[i.e.\\] it is located in a complex anatomical site, extensively invasive, and cannot be completely resected; or a surgical operation may cause dysfunction or serious complications). Symptomatic disease because of active TGCT, defined as a worst pain of greater than or equal to \\[\\>=\\] 4 within 2 weeks prior to enrollment (based on scale of 0 to 10, with 10 representing \"pain as bad as you can imagine\"), and\u002For a worst stiffness of \\>= 4 within 2 weeks prior to first dose of pimicotinib (based on a scale of 0 to 10, with 10 representing \"stiffness as bad as you can imagine\")\n* Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to \\[\\\u003C=\\] 1\n* Participants with adequate hepatic, renal hematologic functions\n* Other protocol defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Known additional malignancy that required active treatment and may affect the participant's participation in the study or affect the outcome of the study as assessed by the Investigator. Exceptions include cured basal cell carcinoma of skin, squamous cell carcinoma of skin, and other carcinoma in situ\n* Serious gastrointestinal bleeding within 3 months of first dose of pimicotinib or factors that significantly affected the absorption of oral drug, such as inability to take oral medication or significant nausea and vomiting, malabsorption, external bile duct drainage, massive small-bowel resection, etc.\n* Impaired cardiac function or clinically significant cardiac disease, including any one of the following: New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure; prolongation of the rate corrected QT interval based on repeated demonstration of QT interval corrected using Fridericia's formula (QTcF) greater than (\\>) 480 milliseconds (ms), or history of long QT interval corrected (QTc) syndrome; Left ventricular ejection fraction (LVEF) less than (\\\u003C) 50 percent (%) or below the lower limit of normal, whichever is higher\n* Cerebrovascular accident\u002Fstroke (within 6 months of first dose of pimicotinib)\n* Other protocol defined exclusion criteria may apply","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The primary purpose of this study is to assess the tolerability, pharmacokinetics, and efficacy of pimicotinib in Japanese participants with TGCT",[26],"Tenosynovial Giant Cell Tumor",[28,29,30,31],"Nodular TGCT","diffuse TGCT","giant cell tumor of tendon sheath","colony-stimulating factor 1 receptor (CSF-1R) inhibitor","RECRUITING","2026-06-15",{"date":35,"type":36},"2026-06-16","ACTUAL",{"date":38,"type":36},"2026-03-26",{"date":40,"type":20},"2029-11-22",{"name":42,"class":43},"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","INDUSTRY",3,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100377270","phase-1-a-study-to-assess-the-safety-tolerability-and-pharmacokinetics-of-absk-021-in-patients-with-advanced-solid-tumor-100377270","NCT04192344","A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor","A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor","Inclusion Criteria:\n\n* Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists\n* ECOG (electrocorticogram) performance status 0\\~1\n* Life expectancy ≥ 3 months\n* Adequate organ function and bone marrow function\n\nFor patients with tenosynovial giant cell tumor (TGCT) :\n\n1. A diagnosis of TGCT \\[i ncluding pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi disciplinary tumor board);\n2. Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;\n3. Others\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to any component of the investigational drug product Previous treatment with CSF-1(colony stimulating factor 1)\u002FCSF-1R (colony stimulating factor 1 receptor) pathway inhibitors\n* Known additional malignancy that is progressing or required active treatment within 3 years of the first dose of study treatment\n* Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication\n* Previous anti-cancer therapy, including chemotherapy, radiotherapy, endocrine therapy or molecular targeted therapy within ≤ 5-halflife or ≤ 4 weeks (whichever is shorter) prior to initiation of study treatment (chemotherapy with nitrosourea or mitomycin should be 6 weeks prior to initiation of study treatment)\n* Major surgery within 4 weeks of the first dose of study drug and all surgical wounds must be healed and free of infection or dehiscence\n* Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤2 severity (CTCAE v5.0) with the exception of alopecia and vitiligo\n* Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of the first dose of study drug\n* Concomitant use of strong inhibitors or inducers of CYP3A4\n* Active central nervous system (CNS) metastases\n* Impaired cardiac function or clinically significant cardiac disease\n* Patients with Gilbert's Syndrome or other underlying conditions that may lead to a greater likelihood of developing LFT(liver function test) abnormalities during the study\n* Known human immunodeficiency virus or active hepatitis B, or active hepatitis C infection\n* Refractory\u002Funcontrolled ascites or pleural effusion\n* Pregnant or nursing\n\nFor patients with tenosynovial giant cell tumor (TGCT) :\n\n1. Known allergy or hypersensitivity to any component of the investigational drug product\n2. For expansion part, previous treatment with CSF 1\u002FCSF 1R pathway inhibitors (not applicable for TGCT patients in US）\n3. Others",{"count":53,"type":20},276,[55],"PHASE1","This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.",[58,26],"Neoplasms",[26,60,61],"TGCT","Solid tumors","2026-03-17",{"date":64,"type":36},"2026-03-19",{"date":66,"type":36},"2020-01-20",{"date":68,"type":20},"2026-12-31",{"name":70,"class":43},"Abbisko Therapeutics Co, Ltd",17,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"locationsCount":100},"100617224","phase-4-accuracy-of-indocyanine-green-icg-fluorescence-imaging-in-tenosynovial-giant-cell-tumor-surgery-100617224","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.","75 Years",{"count":82,"type":20},40,[84],"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.",[26],[88,89,90,26],"Indocyanine Green","Fluorescence Imaging","Near-Infrared Imaging","2026-01-02",{"date":93,"type":36},"2026-01-05",{"date":91,"type":36},{"date":96,"type":20},"2026-12",{"name":98,"class":99},"Shanghai Jiao Tong University Affiliated Sixth People's Hospital","OTHER",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":110,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":100},"100598744","tenosynovial-giant-cell-tumor-tgct-real-world-participant-experience-with-vimseltinib-100598744","NCT07075471","Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib","Real-World Patient Experience of Vimseltinib for the Treatment of Tenosynovial Giant Cell Tumor","Inclusion Criteria:\n\n1. Diagnosis of TGCT according to medical records\n2. Prescribed vimseltinib per the approved label requirements. Participants are eligible if either (A) the decision to receive vimseltinib has been made but treatment has not yet been initiated or (B) the decision to receive vimseltinib has been made and participant has received first dose of prescribed vimseltinib less than 6 months prior to study enrollment\n3. Has provided informed consent and medical records release\n\nExclusion Criteria:\n\n1. Participant has received any other systemic agent for the treatment of TGCT during the 6 months prior to starting treatment with vimseltinib\n2. Participant has received the first dose of prescribed vimseltinib in the current treatment course more than 6 months before study enrollment\n3. Participant is active in an interventional clinical trial of vimseltinib",{"count":109,"type":20},100,"12 Months","OBSERVATIONAL","The goal of this observational study is to better understand real-world use of vimseltinib, treatment patterns, and health-related quality of life in participants treated with vimseltinib for TGCT.\n\nThis study will collect data in an observational disease registry involving no intervention to the participants and will not influence standard medical care or impact treatment decisions for participants.",[26],"2025-11-04",{"date":116,"type":36},"2025-11-05",{"date":118,"type":36},"2025-09-03",{"date":120,"type":20},"2027-09",{"name":122,"class":43},"Deciphera Pharmaceuticals, LLC",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":132,"studyType":111,"phases":4,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100411252","a-long-term-study-evaluating-hepatotoxicity-associated-with-turalio-pexidartinib-treatment-100411252","NCT04635111","A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment","A Long-term Study to Further Evaluate the Risk of Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment","Inclusion Criteria:\n\n* Adult participants with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery\n* Age ≥18 years old\n* Emergence of at least one of the following liver test abnormalities due to TURALIO™ (pexidartinib) exposure:\n\n  * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3 × upper limit of normal (ULN) with concurrent total bilirubin (TBIL) \\>2 × ULN\n  * Isolated TBIL \\>2 × ULN (excluding patients with Gilbert's syndrome)\n  * Isolated AST or ALT \\>10 × ULN\n  * Alkaline phosphatase (ALP) \\>2 x ULN with gamma-glutamyl transferase (GGT) \\>2 x ULN\n* Consent to study procedures, long-term safety follow-up, and use of data from the TURALIO™ (pexidartinib) Risk Evaluation and Mitigation Strategy (REMS) program\n\nExclusion Criteria:\n\n* Not applicable",{"count":131,"type":20},30,"10 Years","A study to evaluate the long-term risk of hepatic failure with TURALIO™ (pexidartinib) and the mechanism of liver injury based upon optional liver biopsy information among patients who received or are receiving TURALIO™ (pexidartinib) and experience hepatotoxicity.",[135,26],"Hepatotoxicity",[135,26,137,138],"Pexidartinib","TURALIO™","2025-09-30",{"date":141,"type":36},"2025-10-06",{"date":143,"type":36},"2021-01-07",{"date":145,"type":20},"2036-06-01",{"name":147,"class":43},"Daiichi Sankyo",8]