[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596279":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":18,"responsibleParty":65,"collaborators":10,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":10,"enrollmentInfo":79,"targetDuration":10,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":10,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"streamlining group",null,"radioembolization is performed without MAA scan",[13],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Hyo-Cheol Kim, MD","CONTACT","82-10-5136-5205","radioembolization@snu.ac.kr",[19,35,48,55],{"facility":20,"status":21,"city":22,"state":10,"zip":10,"country":23,"countryCode":10,"cosmosGeoPoint":24,"geoPoint":29,"contacts":30},"National Cancer Center","NOT_YET_RECRUITING","Goyang-si","South Korea",{"type":25,"coordinates":26},"Point",[27,28],126.835,37.65639,{"lat":28,"lon":27},[31],{"name":32,"role":15,"phone":33,"phoneExt":10,"email":34},"In Joon Lee, MD","82-10-6429-2012","2injoon@hanmail.net",{"facility":36,"status":21,"city":37,"state":10,"zip":10,"country":23,"countryCode":10,"cosmosGeoPoint":38,"geoPoint":42,"contacts":43},"Samsung Medical Center","Seoul",{"type":25,"coordinates":39},[40,41],126.9784,37.566,{"lat":41,"lon":40},[44],{"name":45,"role":15,"phone":46,"phoneExt":10,"email":47},"Dong Ho Hyun, MD","82-10-8809-6722","mesentery@never.com",{"facility":5,"status":49,"city":37,"state":10,"zip":10,"country":23,"countryCode":10,"cosmosGeoPoint":50,"geoPoint":52,"contacts":53},"RECRUITING",{"type":25,"coordinates":51},[40,41],{"lat":41,"lon":40},[54],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},{"facility":56,"status":21,"city":37,"state":10,"zip":10,"country":23,"countryCode":10,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"Severance hospital",{"type":25,"coordinates":58},[40,41],{"lat":41,"lon":40},[61],{"name":62,"role":15,"phone":63,"phoneExt":10,"email":64},"Gyoung Min Kim, MD","821042430703","gyoungmin@gmail.com",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Hyo-Cheol Kim","Professor","100596279","streamlining-radioembolization-for-ccc-and-metastatic-liver-cancer-100596279",false,"NCT07043387","Streamlining Radioembolization for CCC and Metastatic Liver Cancer","Streamlining Radioembolization for Cholangiocarcinoma or Metastatic Liver Cancer ≤ 7 cm : Multicenter Prospective Registry Study","ISTAR-03","Inclusion Criteria:\n\n* Adult aged 19 and over\n\n  * metastatic liver cancer or cholangiocarcinoma\n\n    * the diameter of the largest tumor ≤ 7cm, tumor number 5 or less\n\n      * FLR volume \\> 30% of total non-tumorous liver volume\n\n        * Dysmorphic intratumoral vessel : absent, if present, 3mm or thinner ⑥ Child-Pugh class A\n\n          * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 ⑧ No major organ dysfunction according to blood test performed within two months of study enrollment A. Leukocytes ≥ 1,000\u002FµL and ≤ 20,000\u002FµL B. Hemoglobin ≥ 6.0 g\u002FdL (transfusion allowed to meet this criterion) C. Total bilirubin ≤ 2.0 mg\u002FdL D. Platelet ≥ 40,000\u002FµL E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants F. Aspartate transaminase (AST) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit) G. Alanine transaminase (ALT) ≤ 800 IU\u002FL (i.e., ≤ 20X upper normal limit) H. Creatinine ≤ 2.5 mg\u002FdL (If patients is undergoing hemodialysis, no limit of creatinine) ⑨ Patients with a life expectancy of more than 3 months ⑩ For women of childbearing age, a negative serum pregnancy test. ⑪ Patients who have adequately understood the clinical trial and consented in writing\n\nExclusion Criteria:\n\n* hepatic vein invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI)\n* Hepatic vein enhancement on arterial phase CT\u002FMRI\n* dysmorphic intratumoral vessel \\> 3mm on arterial phase CT\u002FMRI\n* TIPS is present\n* Lobar portal vein enhancement on arterial phase CT\u002FMRI due to AP shunt\n* main portal vein tumor thrombosis\n* Cases where the operator judges that the occurrence of even mild radiation pneumonitis could be fatal, based on marked emphysema or interstitial lung disease findings on chest CT\n* biliary stent or bilioenteric anastomosis\n* History of severe allergy of intolerance to contrast agents\n* Contraindication to angiography or selective visceral catheterization","ALL","19 Years",{"count":80,"type":81},60,"ESTIMATED","OBSERVATIONAL","TARE uses radioactive microspheres (20-60 μm), which are trapped in tumors due to abnormal vasculature, while normal liver sinusoids (≤15 μm) prevent their passage. However, some microspheres may drain into hepatic veins and reach the lungs, risking radiation pneumonitis. Pre-procedural evaluation with angiography and nuclear imaging (MAA scan with SPECT\u002FCT) is required to calculate lung shunt fraction (LSF). TARE is contraindicated if LSF \\>20%, and may be used with caution if LSF is 10-20%.\n\nFindings associated with high LSF include large tumors, hepatic vein invasion, TIPS, and dysmorphic intratumoral vessels. In contrast, small or medium sized (\\\u003C7 cm) cholangiocarcinoma or metastatic liver cancers without hepatic vein invasion or dysmorphic vessels show consistently low LSF (\\\u003C5%). Over 10 years at SNUH, no cases of radiation pneumonitis have been observed in such patients. Therefore, \"streamlining TARE\" omits pre-procedural nuclear imaging for this group to reduce procedural delays, reserving nuclear imaging for patients who need it most.\n\nSIR-Spheres (SIRTEX) facilitate single-session TARE as they are provided in a bulk vial, unlike TheraSphere which requires advance preparation based on dosimetry.\n\nProtocol Overview :\n\nProcedure: Same-day angiography, cone-beam CT, and TARE using SIR-Spheres.\n\nDosimetry: Lung shunt fraction is assumed as 5%, estimated lung dose is capped at 10 Gy.\n\nTumor dose goal: 80\\~400 Gy (around 250Gy)(single-compartment MIRD), or 300 \\~ 1000 Gy (multi-compartment MIRD). minimal tumor dose by partition dosimetry : 100Gy\n\nSoftware: Simplicit90Y for planning, Y90 PET\u002FCT the next day for post-treatment dosimetry.\n\nFollow-up: 1 year; additional treatments follow institutional guidelines.\n\nThis streamlined approach maximizes efficiency while maintaining safety in selected patients.",[85,86,87],"Metastatic Colorectal Carcinoma (mCRC)","Metastatic Liver Cancer","Cholangiocarcinoma","2025-07-21",{"date":90,"type":91},"2025-07-24","ACTUAL",{"date":93,"type":91},"2025-06-22",{"date":95,"type":81},"2029-06-30",{"name":5,"class":6},4]