Cardio and Renovascular Effects of Static Muscle Work in the Healthy Human - Measured With Finapres® and Positron Emission Tomography (PET) Using 15-oxygen Labeled Water as Tracer Compared to Magnetic Resonance (MR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Coefficient of variation on total blood flow and regional renal perfusion measurements at rest and during isometric muscle exercise, measured by PET/CT with 15-Oxygen labeled water and MRI
研究概览
简要总结
This randomized crossover study aims to validate measurements of renal perfusion in healthy males with PET/CT, using 15-oxygen labeled water as tracer, against the validated multiparametric MRI technique.
The study will determine:
- Total renal blood flow and regional renal perfusion at baseline (rest) and during isometric muscle exercise of the upper arm, using PET/CT (with 15-oxygen labeled water as a tracer) and MRI.
- The coefficient of variation of renal blood flow and regional renal perfusion measurements at baseline and during isometric muscle exercise of the upper arm, using PET/CT (with 15-oxygen labeled water as a tracer) and MRI.
- Regional renal oxygenation and oxygen extraction at baseline and during isometric muscle exercise of the upper arm using MRI.
- The coefficient of variation on regional renal oxygenation and oxygen extraction measurements at baseline and during isometric muscle exercise of the upper arm using MRI.
详细描述
Measuring tissue perfusion with PET/CT using 15-oxygen labeled water is routinely used as a non-invasive tool to examine cerebral and myocardial perfusion. With a 100% tissue extraction, 15-oxygen labeled water is gold standard.
The aim of the present study is to validate renal perfusion measurements with PET/CT using 15-oxygen labeled water as tracer against the validated multiparametric MRI technique.
Once validated the imaging technique will be beneficial in examining vascular damage in the kidneys caused by different renal diseases.
This is a randomized, crossover study where each participant will participate in 1 study day.
Ten healthy male participants in the age group 20-60 years are screened and randomized, and expected to complete the present study. Informed consent is obtained before the screening meeting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Normal health stated through medical questionnaire, examination and blood samples.
排除标准
- •Immunosuppressive treatment
- •Alcohol abuse
- •Treatment with glucocorticoids, Glucagon-like peptide-1 (GLP-1) agonists, dipeptidyl peptidase 4 (DPP-4)-inhibitors
- •Medical treatment affecting insulin secretion or cardiovascular endpoints
- •Liver disease
- •Decreased kidney function
- •Severe claustrophobia
- •Elements incompatible with MR.
结局指标
主要结局
Coefficient of variation on total blood flow and regional renal perfusion measurements at rest and during isometric muscle exercise, measured by PET/CT with 15-Oxygen labeled water and MRI
时间窗: Each participant's study day during the span of the study (approximately 5 months)
No metric unit
Total blood flow at rest and during isometric muscle exercise measured by PET/CT with 15-Oxygen labeled water and MRI
时间窗: Each participant's study day during the span of the study (approximately 5 months)
Volume of blood pr unit time, ml/min
Regional renal perfusion at rest and during isometric muscle exercise measured by PET/CT with 15-Oxygen labeled water and MRI
时间窗: Each participant's study day during the span of the study (approximately 5 months)
Volume of blood pr unit time pr unit tissue mass, ml/min/g
Regional renal oxygenation at rest and during isometric muscle exercise using MRI
时间窗: Each participant's study day during the span of the study (approximately 5 months)
Percentage, fraction
Coefficient of variation on regional renal oxygenation and extraction of oxygen measurements at rest and isometric muscle exercise using MRI
时间窗: Each participant's study day during the span of the study (approximately 5 months)
No metric unit
Regional renal extraction of oxygen at rest and during isometric muscle exercise using MRI
时间窗: Each participant's study day during the span of the study (approximately 5 months)
Percentage, fraction
次要结局
未报告次要终点
研究者
Ali Asmar
Chief Physician, Associate Professor
Bispebjerg Hospital