The Clinical Utility of PET-CT in the Management of Squamous Cell Carcinoma of Neck Nodes With an Unknown Primary Malignancy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- proportion of patients where PET/CT resulted in a change in diagnosis
研究概览
简要总结
Historically metastatic squamous cell carcinoma in a cervical lymph node from an occult primary malignancy of the head and neck was evaluated with panendoscopy and biopsies of high risk areas, such as the base of tongue, nasopharynx, and tonsils. This diagnostic protocol identifies the primary malignancy in about 50% of cases. In recent years, the availability of CT has slightly increased the detection rate to 65% when used as an adjunct to the traditional work-up. Studies using PET as an adjunct are conflicting with detection rates ranging up to 75%. Currently, no prospective study has analyzed the role of the PET-CT fusion in the work-up of an occult primary malignancy of the head and neck. This study will compare the detection rate of the traditional work-up to a new protocol involving a pre-operative diagnostic PET-CT.
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
- Single (Care Provider)
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
- •Age > 18 years old
- •Biopsy proven SCC in a cervical lymph node
- •Unknown primary cancer after: History, Physical exam, and office endoscopy by otolaryngologist
- •Negative Chest X-Ray for malignancy
- •Patient consent signed to undergo investigative protocol
排除标准
- •Un-fit for general anesthesia
- •Unable to lie flat for 45 minutes
- •Unable to fast for > 6 hours
- •Unable to perform PET-CT (Obesity > 150kg)
- •Prior Head and Neck cancer
- •Any invasive cancer (Non-Head and Neck) within the last 2 years
研究组 & 干预措施
A
All patients have PET/CT and biopsies with the surgeon blinded to the result of PET/CT. Additional biopsies are performed (or not) after the surgeon has the PET/CT results revealed.
干预措施: PET/CT (Other)
结局指标
主要结局
proportion of patients where PET/CT resulted in a change in diagnosis
时间窗: 2 weeks after surgery
次要结局
未报告次要终点
研究者
Joseph C. Dort
Professor of Surgery
University of Calgary