Quantitative Comparison of Imaging Characteristics of uEXPLORER and Conventional PET/CT in Patients With Lung Cancer, Lymphoma, and Melanoma Undergoing Standard-of-Care FDG-PET/CT for Initial Staging
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Minimum scan duration on a total-body PET/CT scanner for quality
研究概览
简要总结
To determine the minimum scan duration for fluorine-18 positron-emitting radioactive isotope-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)/computed tomography (CT) scans performed on a total-body PET/CT scanner that results in non-inferior image quality to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner. The subject population will be patients being staged for lung cancer, lymphoma, or melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Ability to understand and willingness to sign an informed consent form.
- •Ability to adhere to the study visit schedule and all protocol requirements.
- •Men and women ≥18 years of age.
- •Diagnosis or suspected diagnosis of lung cancer, melanoma or lymphoma.
- •Patients who have been referred for a PET/CT scan.
排除标准
- •Pregnant women.
- •Claustrophobia.
- •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.
研究组 & 干预措施
uEXPLORER/mCT
Each patient will undergo a scan on a total-body PET/CT scanner (uEXPLORER) and then undergo an additional scan on a conventional PET/CT scanner (mCT). The first scan will take place 60 minutes after injection with 18F-FDG and the second scan will be 90 minutes after injection with 18F-FDG.
干预措施: uEXPLORER/mCT (Device)
mCT/uEXPLORER
Each patient will undergo a scan on a conventional PET/CT scanner (mCT) and then undergo an additional scan on a total-body PET/CT scanner (uEXPLORER) . The first scan will take place 60 minutes after injection with 18F-FDG and the second scan will be 90 minutes after injection with 18F-FDG.
干预措施: mCT/uEXPLORER (Device)
结局指标
主要结局
Minimum scan duration on a total-body PET/CT scanner for quality
时间窗: One imaging visit up to two hours
To determine the minimum scan duration for 18F-FDG PET/CT scans performed on a total-body PET/CT scanner that results in non-inferior image quality to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner over 20 minutes.
次要结局
- Minimum scan duration on a total-body PET/CT scanner for tumor recognition(One imaging visit up to two hours)