[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054003":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":47,"responsibleParty":194,"collaborators":26,"id":196,"slug":197,"hasResults":198,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":198,"sex":204,"minAge":205,"maxAge":26,"enrollmentInfo":206,"targetDuration":26,"studyType":209,"phases":210,"briefSummary":212,"conditions":213,"keywords":216,"overallStatus":226,"whyStopped":26,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"fullName":5,"class":6},"Heinrich-Heine University, Duesseldorf","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ICG-Guided Sentinel Lymph Node Biopsy plus Orchiectomy","EXPERIMENTAL","Participants undergo minimally invasive ICG-guided retroperitoneal sentinel lymph node biopsy followed by radical inguinal orchiectomy. After surgery, patients undergo guideline-based surveillance without routine adjuvant therapy.",[13],"Procedure: ICG-Guided Retroperitoneal Sentinel Lymph Node Biopsy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Orchiectomy and Surveillance","ACTIVE_COMPARATOR","Participants undergo radical inguinal orchiectomy followed by guideline-based surveillance according to current clinical practice.",[19],"Procedure: Radical Inguinal Orchiectomy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","ICG-Guided Retroperitoneal Sentinel Lymph Node Biopsy","Minimally invasive laparoscopic or robot-assisted retroperitoneal sentinel lymph node biopsy performed after intratesticular injection of indocyanine green (ICG) using near-infrared fluorescence imaging for sentinel lymph node identification.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Radical Inguinal Orchiectomy","Standard radical inguinal orchiectomy performed according to current clinical guidelines.",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Peter Albers","Department of Urology, University Hospital of Heinrich Heine University, Düsseldorf","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Yue Che","University Hospital of Cologne",[40,44],{"name":33,"role":41,"phone":42,"phoneExt":26,"email":43},"CONTACT","+49 211 81 18110","peter.albers@med.uni-duesseldorf.de",{"name":45,"role":41,"phone":26,"phoneExt":26,"email":46},"Marieke Vermeulen-Spohn","mariekesofie.vermeulen@med.uni-duesseldorf.de",[48,60,74,91,106,121,136,151,165,179],{"facility":49,"status":26,"city":50,"state":26,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":26},"Helsinki University Hospital","Helsinki","00014","Finland","FI",{"type":55,"coordinates":56},"Point",[57,58],24.93545,60.16952,{"lat":58,"lon":57},{"facility":61,"status":26,"city":62,"state":26,"zip":63,"country":52,"countryCode":53,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"University of Turku","Turku","20520",{"type":55,"coordinates":65},[66,67],22.26869,60.45148,{"lat":67,"lon":66},[70],{"name":71,"role":41,"phone":72,"phoneExt":26,"email":73},"Peter Boström","+35823135925","peter.bostrom@tyks.fi",{"facility":75,"status":26,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"University Hospital Ulm","Ulm","Baden-Wurttemberg","89081","Germany","DE",{"type":55,"coordinates":82},[83,84],9.99155,48.39841,{"lat":84,"lon":83},[87],{"name":88,"role":41,"phone":89,"phoneExt":26,"email":90},"Friedemann Zengerling","+49731500-58004","carola.schmid@uniklinik-ulm.de",{"facility":92,"status":26,"city":93,"state":94,"zip":95,"country":79,"countryCode":80,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"University Hospital Würzburg","Würzburg","Bavaria","97080",{"type":55,"coordinates":97},[98,99],9.95121,49.79391,{"lat":99,"lon":98},[102],{"name":103,"role":41,"phone":104,"phoneExt":26,"email":105},"Charis Kalogirou","+49 931 201-32012","breitenste_a@ukw.de",{"facility":107,"status":26,"city":108,"state":109,"zip":110,"country":79,"countryCode":80,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Asklepios Klinik Altona","Hamburg","Free and Hanseatic City of Hamburg","22763",{"type":55,"coordinates":112},[113,114],9.99302,53.55073,{"lat":114,"lon":113},[117],{"name":118,"role":41,"phone":119,"phoneExt":26,"email":120},"Christian Wülfing","+49 40 1818-81 1661","c.wuelfing@asklepios.com",{"facility":122,"status":26,"city":123,"state":124,"zip":125,"country":79,"countryCode":80,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"University Hospital Marbug","Marburg","Hesse","35043",{"type":55,"coordinates":127},[128,129],8.77069,50.80904,{"lat":129,"lon":128},[132],{"name":133,"role":41,"phone":134,"phoneExt":26,"email":135},"Julia Heinzelbecker","+49 64215866239","Julia.Heinzelbecker@uk-gm.de",{"facility":137,"status":26,"city":138,"state":139,"zip":140,"country":79,"countryCode":80,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"University Hospital Cologne","Cologne","North Rhine-Westphalia","50937",{"type":55,"coordinates":142},[143,144],6.95,50.93333,{"lat":144,"lon":143},[147],{"name":148,"role":41,"phone":149,"phoneExt":26,"email":150},"Axel Heidenreich","+49 221 478-82108","kirsten.funke@uk-koeln.de",{"facility":152,"status":26,"city":153,"state":139,"zip":154,"country":79,"countryCode":80,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"University Hospital Düsseldorf","Düsseldorf","40225",{"type":55,"coordinates":156},[157,158],6.77927,51.22319,{"lat":158,"lon":157},[161,162,164],{"name":33,"role":41,"phone":42,"phoneExt":26,"email":43},{"name":163,"role":41,"phone":26,"phoneExt":26,"email":46},"Marieke Vermeulen",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":166,"status":26,"city":167,"state":139,"zip":168,"country":79,"countryCode":80,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Helios University Hospital Wuppertal","Wuppertal","42283",{"type":55,"coordinates":170},[171,172],7.14816,51.25627,{"lat":172,"lon":171},[175],{"name":176,"role":41,"phone":177,"phoneExt":26,"email":178},"Friedrich von Rundstedt","+49202 896-3407","friedrich.vonrundstedt@helios-gesundheit.de",{"facility":180,"status":26,"city":181,"state":182,"zip":183,"country":79,"countryCode":80,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"University Hospital Dresden","Dresden","Saxony","01307",{"type":55,"coordinates":185},[186,187],13.73832,51.05089,{"lat":187,"lon":186},[190],{"name":191,"role":41,"phone":192,"phoneExt":26,"email":193},"Christian Thomas","+49 3514582447","christian.thomas@ukdd.de",{"type":195,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100054003","minimally-invasive-icg-guided-retroperitoneal-sentinel-lymph-node-dissection-in-the-primary-staging-of-testicular-cancer-versus-standard-of-care-100054003",false,"NCT07699640","Minimally-invasive ICG-guided Retroperitoneal Sentinel Lymph Node Dissection in the Primary Staging of Testicular Cancer Versus Standard of Care","RAISN 2: Prospective Randomized Trial of Minimally-invasive ICG-guided Retroperitoneal Sentinel Lymph Node Dissection in the Primary Staging of Testicular Cancer Versus Standard of Care","RAISN 2","Inclusion Criteria:\n\n* Male participants aged 18 years or older.\n* Clinically suspected testicular germ cell tumor based on physical examination and scrotal ultrasonography, with or without elevated serum tumor markers (AFP and\u002For β-hCG).\n* No radiological evidence of metastatic disease on preoperative contrast-enhanced computed tomography (CT) of the chest and abdomen (clinical stage I).\n* Eligible for radical inguinal orchiectomy.\n* Able to understand the study procedures and provide written informed consent.\n* Willing and able to comply with the study protocol and follow-up schedule.\n\nExclusion Criteria:\n\n* Previous scrotal or retroperitoneal surgery unrelated to germ cell tumor treatment, except surgery for cryptorchidism during childhood.\n* Previous malignancy requiring abdominal surgery, chemotherapy, or radiotherapy that could interfere with study participation.\n\nPrevious radiotherapy involving the retroperitoneum.\n\n* Known hypersensitivity to indocyanine green (ICG), iodine, or sodium iodide.\n* Severe medical condition that precludes surgery or study participation.\n* Psychiatric disorder or other condition preventing compliance with study procedures.\n* Inability to understand the German language sufficiently to provide informed consent and complete study assessments.\n* Individuals under legal guardianship or otherwise unable to provide legally valid informed consent.","MALE","18 Years",{"count":207,"type":208},171,"ESTIMATED","INTERVENTIONAL",[211],"NA","Testicular cancer is highly curable, but approximately 20-30% of patients with clinical stage I disease harbor occult retroperitoneal lymph node metastases that are not detected by conventional imaging. Current risk-adapted management may lead to overtreatment in some patients while failing to identify others who are at increased risk of relapse.\n\nThe RAISN 2 study evaluates whether minimally invasive indocyanine green (ICG)-guided retroperitoneal sentinel lymph node dissection can improve primary staging and risk stratification in patients with clinical stage I testicular cancer. Participants will be randomized in a 5:1 ratio to undergo either orchiectomy combined with ICG-guided sentinel lymph node dissection or standard orchiectomy followed by guideline-based surveillance.\n\nAll participants will undergo structured follow-up according to current clinical guidelines. The primary objective is to estimate the 2-year relapse-free survival of patients undergoing the sentinel lymph node approach. Secondary objectives include assessment of overall survival, relapse patterns, perioperative morbidity, quality of life, psychological outcomes, and the feasibility and safety of the procedure.\n\nThis multicenter study aims to determine whether sentinel lymph node-guided staging provides more accurate risk stratification while avoiding unnecessary treatment and maintaining oncological safety.",[214,215],"Testicular Cancer","Testicular Germ Cell Tumor",[214,215,217,218,219,220,221,222,223,224,225],"Stage I Testicular Cancer","Sentinel Lymph Node Biopsy","Sentinel Lymph Node Mapping","Indocyanine Green","ICG","Retroperitoneal Lymph Nodes","Minimally Invasive Surgery","Robot-Assisted Surgery","Active Surveillance","NOT_YET_RECRUITING","2026-07-08",{"date":229,"type":230},"2026-07-13","ACTUAL",{"date":232,"type":208},"2027-01",{"date":234,"type":208},"2031-01",{"name":5,"class":6},10]