Characterizing Dynamics of FDG Uptake With Total-Body PET for Response Assessment in Radiotherapy for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Utility of long-delayed FDG PET Imaging
研究概览
简要总结
The overall goal of this research study is to understand how 18F-fluorodeoxyglucose (FDG), a radioactive sugar behaves in head and neck cancer (HNC) and inflammation immediately following injection and at many hours post-injection, with the world's first total-body positron emission tomography (PET)/computed tomography (CT) scanner (EXPLORER).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Stage II-IVa (American Joint Committee on Cancer, 8th edition) OC who are planned for RT (≥60 Gy) as per routine clinical standard.
- •Patient must be ≥18 years of age.
- •Willing and able to lay motionless in a supine position for up to 60 minutes
- •Patient must be able to provide study specific informed consent prior to study entry.
- •Patient must be able to adhere to the study visit schedule and other protocol requirements (including prolonged fasting).
排除标准
- •Prior RT for any malignancy leading to overlap with planned RT fields.
- •Prior chemotherapy for any malignancy.
- •Subjects suffering from severe claustrophobia.
- •Subjects who have had a research study involving radiation within one year of enrolling in this study
- •Subjects who are pregnant (subjects 18 to 60 years old who are able to become pregnant unless documented hysterectomy or bilateral ovarian removal is available will be tested prior to injection of imaging agent - positive test will exclude from participating in the study)
- •Subjects who are breastfeeding
- •Any significant medical condition that in the opinion of the investigator would prevent the subject from participating and/or adhering to study related procedures or interfere with subject safety (e.g., poorly controlled diabetes).
- •Children (<18 years of age).
- •Body weight more than 240 kg (529 pounds)
研究组 & 干预措施
Total-body PET scan
All participants are asked to complete two study scan visits. First visit occurs before treatment and the second visit occurs 12 +/- 2 weeks after treatment. Each visit will involve a single injection of FDG, followed by three PET/CT scans that will start immediately following injection, at about 2 hours post-injection and at 5 hours post-injection, respectively and last about 60 minutes, 20 minutes and 20 minutes, respectively.
干预措施: Total Body PET/CT Imagin (Diagnostic Test)
结局指标
主要结局
Utility of long-delayed FDG PET Imaging
时间窗: Percent change from baseline to 2 hour post injection
The retention index based on the SUVmax for Oral Cancer and Radiotherapy-induced inflammation
次要结局
未报告次要终点