NL-OMON53440招募中不适用
FDG-PET/CT to reduce the need for sentinel lymph node biopsy in early-stage oral cancer. - PETN0
niversitair Medisch Centrum Utrecht0 个研究点目标入组 159 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 159
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •To be eligible to participate in this study, a subject must meet all of the
- •following criteria:
- •Newly diagnosed early-stage OSCC is defined as clinically T1-3, N0 (only when
- •T3 is assessed based on tumor dimensions of >2 cm and <=4 cm with DOI >10 mm)
- •The patient is >=18 years of age at the time of consent.
- •The patient has no palpable lymph nodes in the neck.
- •Clinical nodal staging (cN0) has been confirmed by ultrasound, CT, and/or MRI
- •if performed (not mandatory).
- •The patient is a candidate for transoral excision and SLNB.
- •The patient has provided written informed consent authorization before
- •participating in the study.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •The patient has other pathologies than squamous cell carcinoma;
- •The patient has recurrent primary oral squamous cell carcinoma;
- •The patient has a history of treatment of the neck (neck dissection and/or
- •radiotherapy);
- •The patient has ultrasound guided fine needle aspiration cytology positive
- •for lymph node metastasis;
- •The patient has poorly controlled diabetes mellitus;
- •The patient refused preoperative imaging workups.
- •A potential subject who meets the following criteria will only be excluded for
- •the contrast-enhanced CT of the head and neck:
- •The patient has had a previous allergic reaction after administration of
- •contrast fluid.
研究者
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