NL-OMON25423招募中不适用
A randomized controlled trial to compare near-infrared fluorescence imaging with standard-of-care sentinel lymph node mapping in vulvar cancer patients
eiden University Medical Center (LUMC)0 个研究点目标入组 48 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
研究概览
简要总结
Crane LM, Themelis G, Arts HJ et al. Intraoperative near-infrared fluorescence imaging for sentinel lymph node detection in vulvar cancer: first clinical results. Gynecol Oncol 2011;120:291-295.
- Schaafsma BE, Verbeek FP, Peters AA et al. Near-infrared fluorescence sentinel lymph node biopsy in vulvar cancer: a randomised comparison of lymphatic tracers. BJOG 2013;120:758-764.
- Hutteman M, van der Vorst JR, Gaarenstroom KN et al. Optimization of near-infrared fluorescent sentinel lymph node mapping for vulvar cancer. Am J Obstet Gynecol 2012;206:89-5
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •T1 squamous cell carcinoma of the vulva (FIGO staging 2009), with a depth of infiltration >1 mm, <4 cm in diameter, unifocal and not encroaching in urethra, vagina or anus, with clinically negative inguinofemoral LNs;
- •Localization and size of the tumor are such that peri-lesional injection of the tracer at 3 or 4 sites is possible;
排除标准
- •Patients with multifocal tumors of the vulva;
- •Patients who show enlarge (>1.5cm)/suspicious lymph nodes at preoperative imaging;
研究者
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