Pilot Study of a 1-Millimeter Resolution Clinical PET System in Head and Neck Cancer Imaging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Acquiring PET images of HNC patients with the 1 mm resolution PET imaging device.
研究概览
简要总结
The purpose of this study is to gain initial experience imaging HNC patient using a new PET camera, a 1mm spacial resolution. The goal is to understand image quality of the system and to see how it works in a clinical environment.
详细描述
PRIMARY OBJECTIVE(S): Gain initial experience imaging head/neck cancer patients using a novel PET camera comprising two opposing panels with 1 millimeter spatial resolution.
SECONDARY OBJECTIVE(S):
- Determine the radioactive dose and scan time required for this novel 1 millimeter (mm) resolution clinical PET camera.
- Images obtained with the 1 mm resolution PET camera will be compared to conventional PET imaging (which will serve as gold standard) for image quality and lesion/node visualization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-confirmed diagnosis of HNC
- •Patient scheduled to undergo surgery for HNC
- •Scheduled to have a PET/CT study on a conventional PET/CT system
- •Age greater than or equal to 19 years of age.
排除标准
- •1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.
研究组 & 干预措施
Novel PET Camera
Patients already undergoing a PET/CT scan for HNC will afterwards undergo a PET scan with the proposed device, thus no additional radioactivity is needed as part of this study.
干预措施: 1-mm Resolution Clinical PET camera (Device)
结局指标
主要结局
Acquiring PET images of HNC patients with the 1 mm resolution PET imaging device.
时间窗: Day 1
PET images of HNC patients with the 1 mm resolution PET imaging device will be qualitatively accessed whether the camera can visualize the primary lesion, including heterogeneity and lymph nodes will be assessed.
次要结局
- Measure image quality of the 1 mm resolution PET imaging device(Day 1)