Reproducibility of 18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Variability of repeated quantitative measures of FDG uptake as measured by SUVmax
研究概览
简要总结
In the current study, the investigators plan to expand the knowledge of Positron Emission Tomography/Magnetic Resonance (PET/MR) reliability by assessing the repeatability of fludeoxyglucose (FDG) standardized uptake values (SUV) measurements, as well as apparent diffusion coefficients (ADC) measurements, in a broad population of patients with malignant solid tumors.
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
- •Patients with histologically confirmed malignant solid tumors (local or metastatic, newly diagnosed or recurrent disease).
- •Patient must have at least one lesion measuring ≥ 2.0 cm.
- •18 years of age or older.
- •Ability to provide informed consent.
排除标准
- •Cancer therapy within 30 days of baseline imaging.
- •Uncontrolled intercurrent illness including, but not limited to active infections.
- •Patients with insulin-dependent diabetes.
- •Patients with metal devices in the body including, but not limited to metallic joint prostheses, artificial heart valves, pacemakers, and cochlear implants.
- •Patients who are pregnant or nursing.
- •Inability to tolerate 60 minutes of PET imaging.
- •Inability to comply with study procedures.
研究组 & 干预措施
FDG-PET/CT and FDG-PET/MR
- 10 mCI fludeoxyglucose IV bolus approximately 60 minutes before first PET/CT
- Immediately following PET/CT scan, the participant will be moved to PET/MR scanner
- The scans will take place at baseline and also one more time point between Day 1 and Day 7. There needs to be at least 24 hours between the baseline and repeat imaging
干预措施: Fludeoxyglucose F 18 (Radiation)
FDG-PET/CT and FDG-PET/MR
- 10 mCI fludeoxyglucose IV bolus approximately 60 minutes before first PET/CT
- Immediately following PET/CT scan, the participant will be moved to PET/MR scanner
- The scans will take place at baseline and also one more time point between Day 1 and Day 7. There needs to be at least 24 hours between the baseline and repeat imaging
干预措施: Positron Emission Tomography (Device)
FDG-PET/CT and FDG-PET/MR
- 10 mCI fludeoxyglucose IV bolus approximately 60 minutes before first PET/CT
- Immediately following PET/CT scan, the participant will be moved to PET/MR scanner
- The scans will take place at baseline and also one more time point between Day 1 and Day 7. There needs to be at least 24 hours between the baseline and repeat imaging
干预措施: Computerized Tomography (Device)
FDG-PET/CT and FDG-PET/MR
- 10 mCI fludeoxyglucose IV bolus approximately 60 minutes before first PET/CT
- Immediately following PET/CT scan, the participant will be moved to PET/MR scanner
- The scans will take place at baseline and also one more time point between Day 1 and Day 7. There needs to be at least 24 hours between the baseline and repeat imaging
干预措施: Magnetic Resonance Imaging (Device)
结局指标
主要结局
Variability of repeated quantitative measures of FDG uptake as measured by SUVmax
时间窗: Completion of study (up to Day 7)
-SUVmax is the maximum standardized uptake value (SUV) of the area of showing metabolic activity and this is used to show response
Variability of repeated quantitative measures of FDG uptake as measured by SUVpeak
时间窗: Completion of study (up to Day 7)
-SUVpeak, which is defined as the average SUV within a 1 cubic cm volume within the region of the tumor with the highest metabolic activity
Repeatability of diffusion-weighted imaging on PET/MR as measured by difference in mean ADC
时间窗: Completion of study (up to Day 7)
* DW MRI is a method of mapping the diffusion process of water within and between tissues * Water diffusion is described quantitatively by apparent diffusion coefficients (ADC)
Repeatability of diffusion-weighted imaging on PET/MR as measured by differences in minimum ADC
时间窗: Completion of study (up to Day 7)
* DW MRI is a method of mapping the diffusion process of water within and between tissues * Water diffusion is described quantitatively by apparent diffusion coefficients (ADC)
次要结局
- Evaluation of the ratio of SUVmax and ADCmin(Completion of study (up to Day 7))