Predictive Value of PET CT in the Histologic Lymph Node Status of Patients With Squamous Cell Carcinoma of the Oral N0 Clinical and Radiological Cavity.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- metastatic lymph node involvement
研究概览
简要总结
Squamous cell carcinoma of the VADS represents the majority of cancers in ENT. Metastatic lymph node involvement is an important prognostic factor. In N0 patients clinically and scanographically, the prevalence of cervical lymph node metastasis remains important. Only the anatomopathological analysis of cervical lymph node dissection confirms the presence of a micro-metastasis. However, new criteria of interpretation in nuclear medicine seem promising in the detection of lymph node lesions not detectable in traditional imaging.
The main objective of this study is to study the positive predictive value (PPV) of CT scans in the anatomo-pathological analysis of N0 clinical and radiological or N + unilateral neck ganglia in patients with squamous cell carcinoma of the oral cavity.
详细描述
The main objective is to study the positive predictive value of PET-CT in the identification of infra-clinical lymph node lesions for cancers of the oral cavity classified N0 or N + unilateral
Patients are admitted to ORL or maxillofacial consultation with initial clinical examination according to current recommendations (tumor evaluation, cervical palpation, locoregional examination).
A dated and signed diagram of the lesion and ganglionic areas will be made during this consultation.
A biopsy for histopathological examination of the lesion will be necessary to confirm the diagnosis of squamous cell carcinoma with P16 analysis. It will be performed during the consultation under local anesthesia if the lesion is accessible or under general anesthesia during panendoscopy.
All patients will benefit from an assessment of locoregional extension by CT cervicofacial and thoracic injected (in order to look for possible pulmonary metastases or suspicious mediastinal lymphadenopathies) as requested in the oncological recommendations and PET-CT. As part of the extension assessment, a panendoscopy or bronchial fibroscopy and gastro-oesophageal failure will be performed if risk factors ethanolotagagic are present.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1st localization of squamous cell carcinoma of the oral cavity.
- •Any tumor T according to the 2017 classification, N0 clinical and radiological or N + unilateral, M0
- •Not challenged for tumor resection surgery and bilateral dissection.
排除标准
- •age <18 years
- •opposition of the curator concerning the person under guardianship
- •subject under guardianship or deprived of liberty
- •antecedent treatment of cancer of the upper aero-digestive tract (surgery, radiotherapy, chemotherapy)
- •any current treatment for another cancer site
结局指标
主要结局
metastatic lymph node involvement
时间窗: 30 days
The outcome is analyzing histologic metastatic lymph node. The outcome data table will include the presence of histologic metastatic lymph node, localization of the lymph invaded, presence of capsular rupture, and preoperative TEP CT data.
次要结局
未报告次要终点