[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054003":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":48,"studyPopulation":39,"armGroups":49,"interventions":62,"overallOfficials":72,"centralContacts":80,"locations":88,"responsibleParty":235,"collaborators":39,"id":237,"slug":39,"hasResults":238,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":238,"sex":244,"minAge":245,"maxAge":39,"enrollmentInfo":246,"targetDuration":39,"studyType":249,"phases":250,"briefSummary":252,"conditions":253,"keywords":256,"overallStatus":266,"whyStopped":39,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},{"fullName":5,"class":6},"Heinrich-Heine University, Duesseldorf","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"2-Year Relapse-Free Survival (RFS)","Relapse-free survival is defined as the time from randomization to the first occurrence of radiologically or histopathologically confirmed disease recurrence, serological progression according to guideline-based clinical assessment, clinically unequivocal progression requiring salvage therapy, or death from any cause, whichever occurs first.","24 months after randomization",[14,17,20,23,27,31,35],{"measure":15,"description":16,"timeFrame":12},"Overall Survival","Overall survival is defined as the time from randomization until death from any cause.",{"measure":18,"description":19,"timeFrame":12},"Time to Tumor Recurrence","Time from randomization to the first documented recurrence.",{"measure":21,"description":22,"timeFrame":12},"Rate of Salvage Therapy","Proportion of participants requiring salvage treatment including chemotherapy, retroperitoneal lymph node dissection, radiotherapy, or other oncological treatment.",{"measure":24,"description":25,"timeFrame":26},"Perioperative Morbidity","Perioperative complications graded according to the Clavien-Dindo classification and the EAU Intraoperative Adverse Incident Classification (EAUiaiC).","up to 30 days after surgery",{"measure":28,"description":29,"timeFrame":30},"Postoperative Complications","Assessment of postoperative complications and long-term morbidity according to the Clavien-Dindo classification.","up to 24 months after surgery",{"measure":32,"description":33,"timeFrame":34},"Health-Related Quality of Life","Quality of life assessed using the EORTC QLQ-C30 and EORTC QLQ-TC26 questionnaires. The EORTC QLQ-C30 is the core, 30-item questionnaire developed by the EORTC Quality of Life Group to evaluate the global health status and general quality of life of cancer patients. It is used alongside disease-specific modules, such as the EORTC QLQ-TC26, which is specifically designed for testicular cancer patients. The combination of these questionnaires ensures that clinicians and researchers capture both the general impacts of a cancer diagnosis and the specific issues pertinent to testicular cancer survivors.","Baseline and annually for 5 years",{"measure":36,"description":37,"timeFrame":38},"Technical Feasibility of Sentinel Lymph Node Biopsy","Feasibility assessed by successful completion of the planned minimally invasive sentinel lymph node biopsy procedure according to the study protocol.","During surgery",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":39,"timePerspective":39,"maskingInfo":45},"RANDOMIZED","PARALLEL","Participants are randomized in a 5:1 ratio to receive either minimally invasive ICG-guided retroperitoneal sentinel lymph node biopsy combined with inguinal orchiectomy or standard inguinal orchiectomy followed by guideline-based surveillance. The unequal allocation was selected to maximize prospective evaluation of the investigational staging procedure while maintaining a concurrent control group.","TREATMENT",{"masking":46,"maskingDescription":47,"whoMasked":39},"NONE","Due to the nature of the surgical intervention, blinding of participants and investigators is not feasible. Outcome assessment is based on predefined clinical, radiological, and pathological criteria.","Testicular germ cell tumors are the most common solid malignancy in young adult men and are associated with excellent long-term survival when managed appropriately. In patients with clinical stage I disease, approximately 20-30% harbor occult retroperitoneal lymph node metastases despite the absence of radiologically detectable disease. Current management strategies rely on histopathological risk factors to guide surveillance or adjuvant treatment; however, these factors have limited predictive accuracy and may result in both overtreatment and undertreatment.\n\nSentinel lymph node (SLN) mapping has been successfully established in several solid malignancies as a minimally invasive method for detecting occult lymphatic metastases. The RAISN feasibility study demonstrated that minimally invasive indocyanine green (ICG)-guided retroperitoneal sentinel lymph node dissection is technically feasible in patients with clinical stage I testicular cancer, achieving a 100% sentinel lymph node detection rate without increasing perioperative morbidity. These findings provide the basis for prospective validation in a larger patient population.\n\nRAISN 2 is a prospective, randomized, multicenter clinical trial designed to evaluate whether ICG-guided retroperitoneal sentinel lymph node dissection improves primary staging and risk stratification in patients with clinical stage I testicular cancer. Eligible participants will be randomized in a 5:1 ratio to receive either minimally invasive ICG-guided sentinel lymph node dissection combined with inguinal orchiectomy (intervention arm) or inguinal orchiectomy followed by guideline-based surveillance (control arm). The unequal allocation was chosen to maximize the prospective evaluation of the novel staging procedure while maintaining a concurrent reference group.\n\nIn the intervention arm, indocyanine green is injected into the affected testis immediately before minimally invasive retroperitoneal exploration. Near-infrared fluorescence imaging is used to identify and remove sentinel lymph nodes for histopathological evaluation. After surgery, patients in both study arms undergo guideline-based surveillance without routine adjuvant treatment. In the event of disease recurrence, salvage therapy is administered according to current national and international guidelines.\n\nThe primary objective of the study is to estimate the 2-year relapse-free survival of patients undergoing the sentinel lymph node strategy. Secondary objectives include evaluation of overall survival, relapse patterns, time to relapse, perioperative morbidity, postoperative complications, quality of life, psychological outcomes, technical feasibility, and safety of the procedure. In addition, translational analyses using prospectively collected blood and tissue samples will explore clinicopathological and molecular factors associated with oncological outcomes.\n\nThe results of this study are expected to determine whether minimally invasive ICG-guided sentinel lymph node dissection can provide more accurate nodal staging, reduce unnecessary treatment, and maintain oncological safety in patients with clinical stage I testicular cancer.",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"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.",[55],"Procedure: ICG-Guided Retroperitoneal Sentinel Lymph Node Biopsy",{"label":57,"type":58,"description":59,"interventionNames":60},"Standard Orchiectomy and Surveillance","ACTIVE_COMPARATOR","Participants undergo radical inguinal orchiectomy followed by guideline-based surveillance according to current clinical practice.",[61],"Procedure: Radical Inguinal Orchiectomy",[63,68],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":39},"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.",[51],{"type":64,"name":69,"description":70,"armGroupLabels":71,"otherNames":39},"Radical Inguinal Orchiectomy","Standard radical inguinal orchiectomy performed according to current clinical guidelines.",[57],[73,77],{"name":74,"affiliation":75,"role":76},"Peter Albers","Department of Urology, University Hospital of Heinrich Heine University, Düsseldorf","PRINCIPAL_INVESTIGATOR",{"name":78,"affiliation":79,"role":76},"Yue Che","University Hospital of Cologne",[81,85],{"name":74,"role":82,"phone":83,"phoneExt":39,"email":84},"CONTACT","+49 211 81 18110","peter.albers@med.uni-duesseldorf.de",{"name":86,"role":82,"phone":39,"phoneExt":39,"email":87},"Marieke Vermeulen-Spohn","mariekesofie.vermeulen@med.uni-duesseldorf.de",[89,101,115,132,147,162,177,192,206,220],{"facility":90,"status":39,"city":91,"state":39,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":39},"Helsinki University Hospital","Helsinki","00014","Finland","FI",{"type":96,"coordinates":97},"Point",[98,99],24.93545,60.16952,{"lat":99,"lon":98},{"facility":102,"status":39,"city":103,"state":39,"zip":104,"country":93,"countryCode":94,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"University of Turku","Turku","20520",{"type":96,"coordinates":106},[107,108],22.26869,60.45148,{"lat":108,"lon":107},[111],{"name":112,"role":82,"phone":113,"phoneExt":39,"email":114},"Peter Boström","+35823135925","peter.bostrom@tyks.fi",{"facility":116,"status":39,"city":117,"state":118,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"University Hospital Ulm","Ulm","Baden-Wurttemberg","89081","Germany","DE",{"type":96,"coordinates":123},[124,125],9.99155,48.39841,{"lat":125,"lon":124},[128],{"name":129,"role":82,"phone":130,"phoneExt":39,"email":131},"Friedemann Zengerling","+49731500-58004","carola.schmid@uniklinik-ulm.de",{"facility":133,"status":39,"city":134,"state":135,"zip":136,"country":120,"countryCode":121,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"University Hospital Würzburg","Würzburg","Bavaria","97080",{"type":96,"coordinates":138},[139,140],9.95121,49.79391,{"lat":140,"lon":139},[143],{"name":144,"role":82,"phone":145,"phoneExt":39,"email":146},"Charis Kalogirou","+49 931 201-32012","breitenste_a@ukw.de",{"facility":148,"status":39,"city":149,"state":150,"zip":151,"country":120,"countryCode":121,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Asklepios Klinik Altona","Hamburg","Free and Hanseatic City of Hamburg","22763",{"type":96,"coordinates":153},[154,155],9.99302,53.55073,{"lat":155,"lon":154},[158],{"name":159,"role":82,"phone":160,"phoneExt":39,"email":161},"Christian Wülfing","+49 40 1818-81 1661","c.wuelfing@asklepios.com",{"facility":163,"status":39,"city":164,"state":165,"zip":166,"country":120,"countryCode":121,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"University Hospital Marbug","Marburg","Hesse","35043",{"type":96,"coordinates":168},[169,170],8.77069,50.80904,{"lat":170,"lon":169},[173],{"name":174,"role":82,"phone":175,"phoneExt":39,"email":176},"Julia Heinzelbecker","+49 64215866239","Julia.Heinzelbecker@uk-gm.de",{"facility":178,"status":39,"city":179,"state":180,"zip":181,"country":120,"countryCode":121,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"University Hospital Cologne","Cologne","North Rhine-Westphalia","50937",{"type":96,"coordinates":183},[184,185],6.95,50.93333,{"lat":185,"lon":184},[188],{"name":189,"role":82,"phone":190,"phoneExt":39,"email":191},"Axel Heidenreich","+49 221 478-82108","kirsten.funke@uk-koeln.de",{"facility":193,"status":39,"city":194,"state":180,"zip":195,"country":120,"countryCode":121,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"University Hospital Düsseldorf","Düsseldorf","40225",{"type":96,"coordinates":197},[198,199],6.77927,51.22319,{"lat":199,"lon":198},[202,203,205],{"name":74,"role":82,"phone":83,"phoneExt":39,"email":84},{"name":204,"role":82,"phone":39,"phoneExt":39,"email":87},"Marieke Vermeulen",{"name":74,"role":76,"phone":39,"phoneExt":39,"email":39},{"facility":207,"status":39,"city":208,"state":180,"zip":209,"country":120,"countryCode":121,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Helios University Hospital Wuppertal","Wuppertal","42283",{"type":96,"coordinates":211},[212,213],7.14816,51.25627,{"lat":213,"lon":212},[216],{"name":217,"role":82,"phone":218,"phoneExt":39,"email":219},"Friedrich von Rundstedt","+49202 896-3407","friedrich.vonrundstedt@helios-gesundheit.de",{"facility":221,"status":39,"city":222,"state":223,"zip":224,"country":120,"countryCode":121,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"University Hospital Dresden","Dresden","Saxony","01307",{"type":96,"coordinates":226},[227,228],13.73832,51.05089,{"lat":228,"lon":227},[231],{"name":232,"role":82,"phone":233,"phoneExt":39,"email":234},"Christian Thomas","+49 3514582447","christian.thomas@ukdd.de",{"type":236,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","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":247,"type":248},171,"ESTIMATED","INTERVENTIONAL",[251],"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.",[254,255],"Testicular Cancer","Testicular Germ Cell Tumor",[254,255,257,258,259,260,261,262,263,264,265],"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":269,"type":270},"2026-07-13","ACTUAL",{"date":272,"type":248},"2027-01",{"date":274,"type":248},"2031-01",{"name":5,"class":6},10]