Minimally-invasive ICG-guided Retroperitoneal Sentinel Lymph Node Dissection in the Primary Staging of Testicular Cancer Versus Standard of Care (RAISN 2)
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
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.
The 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.
All 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.
This multicenter study aims to determine whether sentinel lymph node-guided staging provides more accurate risk stratification while avoiding unnecessary treatment and maintaining oncological safety.
研究概览
地位
详细说明
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.
Sentinel 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.
RAISN 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.
In 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.
The 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.
The 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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Peter Albers
- 电话号码：+49 211 81 18110
- 邮箱：peter.albers@med.uni-duesseldorf.de
研究联系人备份
- 姓名：Marieke Vermeulen-Spohn
- 邮箱：mariekesofie.vermeulen@med.uni-duesseldorf.de
学习地点
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Baden-Wurttemberg
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Ulm、Baden-Wurttemberg、德国、89081
- University Hospital Ulm
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接触：
- Friedemann Zengerling
- 电话号码：+49731500-58004
- 邮箱：carola.schmid@uniklinik-ulm.de
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Bavaria
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Würzburg、Bavaria、德国、97080
- University Hospital Würzburg
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接触：
- Charis Kalogirou
- 电话号码：+49 931 201-32012
- 邮箱：breitenste_a@ukw.de
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Free and Hanseatic City of Hamburg
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Hamburg、Free and Hanseatic City of Hamburg、德国、22763
- Asklepios Klinik Altona
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接触：
- Christian Wülfing
- 电话号码：+49 40 1818-81 1661
- 邮箱：c.wuelfing@asklepios.com
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Hesse
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Marburg、Hesse、德国、35043
- University Hospital Marbug
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接触：
- Julia Heinzelbecker
- 电话号码：+49 64215866239
- 邮箱：Julia.Heinzelbecker@uk-gm.de
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North Rhine-Westphalia
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Cologne、North Rhine-Westphalia、德国、50937
- University Hospital Cologne
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接触：
- Axel Heidenreich
- 电话号码：+49 221 478-82108
- 邮箱：kirsten.funke@uk-koeln.de
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Düsseldorf、North Rhine-Westphalia、德国、40225
- University Hospital Düsseldorf
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接触：
- Peter Albers
- 电话号码：+49 211 81 18110
- 邮箱：peter.albers@med.uni-duesseldorf.de
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接触：
- Marieke Vermeulen
- 邮箱：mariekesofie.vermeulen@med.uni-duesseldorf.de
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首席研究员：
- Peter Albers
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Wuppertal、North Rhine-Westphalia、德国、42283
- Helios University Hospital Wuppertal
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接触：
- Friedrich von Rundstedt
- 电话号码：+49202 896-3407
- 邮箱：friedrich.vonrundstedt@helios-gesundheit.de
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Saxony
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Dresden、Saxony、德国、01307
- University Hospital Dresden
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接触：
- Christian Thomas
- 电话号码：+49 3514582447
- 邮箱：christian.thomas@ukdd.de
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Helsinki、芬兰、00014
- Helsinki University Hospital
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Turku、芬兰、20520
- University of Turku
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接触：
- Peter Boström
- 电话号码：+35823135925
- 邮箱：peter.bostrom@tyks.fi
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Male participants aged 18 years or older.
- Clinically suspected testicular germ cell tumor based on physical examination and scrotal ultrasonography, with or without elevated serum tumor markers (AFP and/or β-hCG).
- No radiological evidence of metastatic disease on preoperative contrast-enhanced computed tomography (CT) of the chest and abdomen (clinical stage I).
- Eligible for radical inguinal orchiectomy.
- Able to understand the study procedures and provide written informed consent.
- Willing and able to comply with the study protocol and follow-up schedule.
Exclusion Criteria:
- Previous scrotal or retroperitoneal surgery unrelated to germ cell tumor treatment, except surgery for cryptorchidism during childhood.
- Previous malignancy requiring abdominal surgery, chemotherapy, or radiotherapy that could interfere with study participation.
Previous radiotherapy involving the retroperitoneum.
- Known hypersensitivity to indocyanine green (ICG), iodine, or sodium iodide.
- Severe medical condition that precludes surgery or study participation.
- Psychiatric disorder or other condition preventing compliance with study procedures.
- Inability to understand the German language sufficiently to provide informed consent and complete study assessments.
- Individuals under legal guardianship or otherwise unable to provide legally valid informed consent.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：ICG-Guided Sentinel Lymph Node Biopsy plus Orchiectomy
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.
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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.
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有源比较器：Standard Orchiectomy and Surveillance
Participants undergo radical inguinal orchiectomy followed by guideline-based surveillance according to current clinical practice.
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Standard radical inguinal orchiectomy performed according to current clinical guidelines.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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2-Year Relapse-Free Survival (RFS)
大体时间：24 months after randomization
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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.
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24 months after randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Survival
大体时间：24 months after randomization
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Overall survival is defined as the time from randomization until death from any cause.
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24 months after randomization
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Time to Tumor Recurrence
大体时间：24 months after randomization
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Time from randomization to the first documented recurrence.
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24 months after randomization
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Rate of Salvage Therapy
大体时间：24 months after randomization
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Proportion of participants requiring salvage treatment including chemotherapy, retroperitoneal lymph node dissection, radiotherapy, or other oncological treatment.
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24 months after randomization
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Perioperative Morbidity
大体时间：up to 30 days after surgery
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Perioperative complications graded according to the Clavien-Dindo classification and the EAU Intraoperative Adverse Incident Classification (EAUiaiC).
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up to 30 days after surgery
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Postoperative Complications
大体时间：up to 24 months after surgery
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Assessment of postoperative complications and long-term morbidity according to the Clavien-Dindo classification.
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up to 24 months after surgery
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Health-Related Quality of Life
大体时间：Baseline and annually for 5 years
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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.
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Baseline and annually for 5 years
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Technical Feasibility of Sentinel Lymph Node Biopsy
大体时间：During surgery
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Feasibility assessed by successful completion of the planned minimally invasive sentinel lymph node biopsy procedure according to the study protocol.
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During surgery
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合作者和调查者
调查人员
- 首席研究员：Peter Albers、Department of Urology, University Hospital of Heinrich Heine University, Düsseldorf
- 首席研究员：Yue Che、University Hospital of Cologne
出版物和有用的链接
一般刊物
- Vermeulen-Spohn MS, Pongratanakul P, Thy S, Dukart J, Albers P, Che Y. RAISN: Robot-assisted Indocyanine Green-guided Sentinel Node Biopsy in Clinical Stage I Germ Cell Tumor. Eur Urol Open Sci. 2024 Jun 27;66:55-59. doi: 10.1016/j.euros.2024.06.004. eCollection 2024 Aug.
- Albers P, Siener R, Krege S, Schmelz HU, Dieckmann KP, Heidenreich A, Kwasny P, Pechoel M, Lehmann J, Kliesch S, Kohrmann KU, Fimmers R, Weissbach L, Loy V, Wittekind C, Hartmann M; German Testicular Cancer Study Group. Randomized phase III trial comparing retroperitoneal lymph node dissection with one course of bleomycin and etoposide plus cisplatin chemotherapy in the adjuvant treatment of clinical stage I Nonseminomatous testicular germ cell tumors: AUO trial AH 01/94 by the German Testicular Cancer Study Group. J Clin Oncol. 2008 Jun 20;26(18):2966-72. doi: 10.1200/JCO.2007.12.0899. Epub 2008 May 5.
- Nayan M, Jewett MA, Hosni A, Anson-Cartwright L, Bedard PL, Moore M, Hansen AR, Chung P, Warde P, Sweet J, O'Malley M, Atenafu EG, Hamilton RJ. Conditional Risk of Relapse in Surveillance for Clinical Stage I Testicular Cancer. Eur Urol. 2017 Jan;71(1):120-127. doi: 10.1016/j.eururo.2016.07.013. Epub 2016 Aug 12.
- Tanis PJ, Horenblas S, Valdes Olmos RA, Hoefnagel CA, Nieweg OE. Feasibility of sentinel node lymphoscintigraphy in stage I testicular cancer. Eur J Nucl Med Mol Imaging. 2002 May;29(5):670-3. doi: 10.1007/s00259-001-0751-8. Epub 2002 Mar 5.
- Blok JM, Kerst JM, Vegt E, Brouwer OR, Meijer RP, Bosch JLHR, Bex A, van der Poel HG, Horenblas S. Sentinel node biopsy in clinical stage I testicular cancer enables early detection of occult metastatic disease. BJU Int. 2019 Sep;124(3):424-430. doi: 10.1111/bju.14618. Epub 2019 Mar 28.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- RAISN 2
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
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