Pilot Study of 18F Fluciclovine PET CT in Identification of the Primary in Patients With an Unknown Primary Head and Neck Squamous Cell Carcinoma Presenting With Metastatic Cervical Nodal Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Proportion of the suspected lesions that are positive by the gold standard of pathology
研究概览
简要总结
This early phase I trial studies how well fluciclovine F18 positron emission tomography (PET)/computed tomography (CT) works in identifying the origin of head and neck squamous cell carcinoma in patients with cancer that has spread to the cervical lymph nodes. Fluciclovine F18 during a PET/CT scan may work better in helping doctors learn where the cancer started (called the site of origin) and directing treatment planning compared to standard fludeoxyglucose F-18 (FDG) PET-CT scans.
详细描述
PRIMARY OBJECTIVES:
I. To estimate positive predictive value with a corresponding 95% confidence interval for fluciclovine F18 (18F fluciclovine) positron emission tomography computed tomography (PET CT) to detect a primary site of disease in patients presenting with cervical metastatic nodal disease but a head and neck primary site not apparent on CT of the neck with contrast (contrast enhanced-computed tomography, CE-CT).
SECONDARY OBJECTIVES:
I. To estimate positive predictive value with a corresponding 95% confidence interval for fludeoxyglucose F-18 (18F FDG) PET CT in the detection of a primary site of disease in patients presenting with cervical metastatic nodal disease but a head and neck primary site not apparent on CT of the neck with contrast.
EXPLORATORY OBJECTIVES:
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
- •Adults with biopsy proven metastatic cervical nodal squamous cell carcinoma
- •CT of the neck with contrast that does not confidently identify a primary oropharyngeal site of disease
- •Planned standard of care 18F-FDG PET CT examination
- •Planned standard of care exam under anesthesia with oropharyngeal surgical biopsy
排除标准
- •Pregnant women
- •Known allergy to FDG, fluciclovine, or iodine-based contrast agents
- •Severe renal dysfunction (glomerular filtrate rate [within 30 days] less than 30)
- •Inability to tolerate lying supine, relatively motionless for up to 1 hour
结局指标
主要结局
Proportion of the suspected lesions that are positive by the gold standard of pathology
时间窗: Up to 2 years
Positive predicative values will be estimated with a corresponding exact 95% confidence interval.
次要结局
未报告次要终点