Utilizing sentinel lymph node biopsy to identify the lymphatic drainage pattern in clinically node negative recurrent oral cavity squamous cell carcinoma. A feasibility study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To identify the patterns of lymphatic drainage patterns in patients
研究概览
简要总结
Sentinel Lymph Node Biopsy (SLNB) has been proven to be an
accurate predictor of lymphatic drainage in treatment of naïve oral
cavity SCC with a sensitivity of 94%. However, necks that have
been previously treated by either surgery or radiotherapy may
have an alteration of lymphatic channels and therefore, erratic
drainage patterns. Clinical and radiological examination of such
necks may not yield an accurate prediction as occult metastasis is
difficult to gauge via these modalities. Appropriate clinical and
pathological staging of these necks is of the essence in the
management of recurrent oral cavity SCCs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Biopsy proven recurrent or second primary invasive squamous cell carcinoma of oral cavity on the side which has previously been treated with neck dissection or radiation 2 Clinicoradiologically T1, T2, T3 tumors with node negative disease and no distant metastases on whole body PET CECT 3 Planned for curative intent surgical excision of the primary tumor with elective neck dissection of the contralateral side.
排除标准
- •1 Patients with reduced mouth opening where peritumoral injection of radiotracer along 4 quadrants not possible 2 Patients who are not suitable for curative intent surgery or neck dissection for medical or surgical reasons 3 Patients in whom bilateral neck dissection has been done in the previous surgery.
结局指标
主要结局
To identify the patterns of lymphatic drainage patterns in patients
时间窗: 1 Month
with recurrent OSCC with previously treated neck
时间窗: 1 Month
次要结局
- To study the accuracy of PET CECT and SLNB for detection of LN metastases in recurrent OSCC as compared to the final histopathology report(1 Month)
- To assess the sensitivity, specificity, positive and negative predictive value of SLNB(1 Month)
研究者
Dr Vidisha Tuljapurkar
Tata Memorial Hospital