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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Peter Albers
- 電話番号：+49 211 81 18110
- メール：peter.albers@med.uni-duesseldorf.de
研究連絡先のバックアップ
- 名前：Marieke Vermeulen-Spohn
- メール：mariekesofie.vermeulen@med.uni-duesseldorf.de
研究場所
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Baden-Wurttemberg
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Ulm、Baden-Wurttemberg、ドイツ、89081
- University Hospital Ulm
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コンタクト：
- Friedemann Zengerling
- 電話番号：+49731500-58004
- メール：carola.schmid@uniklinik-ulm.de
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Bavaria
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Würzburg、Bavaria、ドイツ、97080
- University Hospital Würzburg
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コンタクト：
- Charis Kalogirou
- 電話番号：+49 931 201-32012
- メール：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、ドイツ、22763
- Asklepios Klinik Altona
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コンタクト：
- Christian Wülfing
- 電話番号：+49 40 1818-81 1661
- メール：c.wuelfing@asklepios.com
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Hesse
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Marburg、Hesse、ドイツ、35043
- University Hospital Marbug
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コンタクト：
- Julia Heinzelbecker
- 電話番号：+49 64215866239
- メール：Julia.Heinzelbecker@uk-gm.de
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North Rhine-Westphalia
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Cologne、North Rhine-Westphalia、ドイツ、50937
- University Hospital Cologne
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コンタクト：
- Axel Heidenreich
- 電話番号：+49 221 478-82108
- メール：kirsten.funke@uk-koeln.de
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Düsseldorf、North Rhine-Westphalia、ドイツ、40225
- University Hospital Düsseldorf
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コンタクト：
- Peter Albers
- 電話番号：+49 211 81 18110
- メール：peter.albers@med.uni-duesseldorf.de
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コンタクト：
- Marieke Vermeulen
- メール：mariekesofie.vermeulen@med.uni-duesseldorf.de
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主任研究者：
- Peter Albers
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Wuppertal、North Rhine-Westphalia、ドイツ、42283
- Helios University Hospital Wuppertal
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コンタクト：
- Friedrich von Rundstedt
- 電話番号：+49202 896-3407
- メール：friedrich.vonrundstedt@helios-gesundheit.de
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Saxony
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Dresden、Saxony、ドイツ、01307
- University Hospital Dresden
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コンタクト：
- Christian Thomas
- 電話番号：+49 3514582447
- メール：christian.thomas@ukdd.de
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Helsinki、フィンランド、00014
- Helsinki University Hospital
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Turku、フィンランド、20520
- University of Turku
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コンタクト：
- Peter Boström
- 電話番号：+35823135925
- メール：peter.bostrom@tyks.fi
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参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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2-Year Relapse-Free Survival (RFS)
時間枠：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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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall Survival
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
捜査官
- 主任研究者：Peter Albers、Department of Urology, University Hospital of Heinrich Heine University, Düsseldorf
- 主任研究者：Yue Che、University Hospital of Cologne
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- RAISN 2
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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