A Feasibility Trial of Lymphatic Mapping With SPECT-CT for Evaluating Contralateral Disease in Lateralized Oropharynx Cancer Using 99m-Technetium Sulfur Colloid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 8
- 主要终点
- Proportion of patients with images that failed radiotracer migration to either side of the neck.
研究概览
简要总结
The purpose of the study is to see how practical it is to inject a radiotracer called 99m-Technetium Sulfur Colloid around the tumors for the imaging of patients with oropharyngeal cancer.
详细描述
This study will evaluate a technique called lymphatic drainage mapping. This is a technique where a radiotracer (a radioactive material that can be seen with a special computed tomography [CT] scanner to create 3D images) is injected into a vein around the tumour, either with local anesthesia or under general anesthesia. The radiotracer that will be used for the lymphatic drainage mapping is called 99m-Technetium Sulfur Colloid. Images will be taken of neck to detect the movement of the radiotracer. This will allow the doctors to see the drainage pattern of the lymph nodes in the neck.
The information from this study will be used to better understand the tendency for oropharyngeal cancers to spread to lymph nodes. In addition, the information from this clinical trial will be used in future clinical studies to help specialists identify strategies to help plan treatment based on this type of imaging study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient has lateralized oropharyngeal carcinoma (tonsil or tongue base) not involving midline
- •Has squamous cell carcinoma, T1-3 tumours, with no contralateral nodes on clinical exam or axial imaging
- •Human papillomavirus (HPV) positive or negative
- •Patient should have normal organ function as per Investigator judgement
- •Patient is planned for definitive or adjuvant radiotherapy (RT) or chemo radiotherapy (CRT) with bilateral neck RT, or surgery
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
排除标准
- •T4 tumours
- •Contralateral/bilateral nodal disease or node(s) > 6cm on clinical exam or axial imaging or positron emission tomography (PET)
- •Primary tumour involving or crossing midline
- •Soft palate or posterior pharyngeal wall tumour subsites
- •Previous head and neck cancer
- •Previous radiotherapy (RT) to the head and neck
- •Previous neck dissection
- •Distant metastases
- •Prior invasive malignancy (except non-melanoma skin cancer) unless disease free for 3 years
- •Prior radiotracer allergy
- •Multiple primary head and neck cancers
- •Pregnancy
结局指标
主要结局
Proportion of patients with images that failed radiotracer migration to either side of the neck.
时间窗: 1 year
Proportion of patients completing 3 hour scan.
时间窗: 1 year
Proportion of patients requiring general anesthetic over local anesthetic.
时间窗: 1 year
Proportion of patients injected with radiotracer.
时间窗: 1 year
Proportion of patients completing 30 minute scan.
时间窗: 1 year
Proportion of patients with injections site locations that are compliant with protocol specific map of injection locations.
时间窗: 1 year
Average time from start to finish of injection of procedure.
时间窗: 1 year
Proportion of patients with radiotracer uptake into a radiographically positive lymph node.
时间窗: 1 year
Proportion of patients with complications associated with injection.
时间窗: 1 year
次要结局
未报告次要终点