Renal Blood Flow Measurement With PET
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Obtain preliminary information on efficacy for quantification of regional renal perfusion in two target clinical populations with a full range of renal disease using 150-water PET and 62Cu-ETS PET
研究概览
简要总结
Two investigational chemical tracers, 62Cu-ethylglyoxal bis(thiosemicarbazone) (62Cu-ETS) and 15O-water, will be used in this study to look at how blood moves through the kidneys. The purpose of the study is to see if 62Cu-ETS is effective in showing the blood supply to the kidneys compared to 15O-water. The tracer mixes with the blood and moves through the body. Using positron emission tomography (PET scan) the researchers can see the tracer and can learn more about how the blood moves through the kidneys. The study invites participants who are healthy, without any heart or kidney disease, patients who have kidney disease that require dialysis, and patients who may have a blockage in one of the arteries supplying blood to the kidneys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •males and females, age 18-40 years
- •willingness to provide written informed consent
排除标准
- •history of coronary artery disease (CAD)
- •history of renal disease
- •risk factors for cardiac disease, renal disease, or atherosclerosis, including diabetes mellitus, hypertension, tobacco abuse, hyperlipidemia, family history of CAD or chronic renal failure
- •history of liver disease or other significant disease
- •pregnant females
- •Inclusion Criteria:
- •males and females, age > 18 years
- •active hemodialysis or peritoneal dialysis for at least six months
- •any etiology of chronic renal failure except active glomerular nephritis
- •presence of two kidneys
- •willingness to provide written informed consent
- •Exclusion Criteria:
- •decompensated heart failure (subjects must be on stable medical therapy for one month)
- •any previous renal transplant (subjects may be on renal transplant waiting list)
- •history of liver disease
- •pregnant females
- •Inclusion Criteria:
- •males and females, age > 18 years
- •documented evidence of renal artery stenosis equivalent to a 75% stenosis by one of the following clinical tests: MRA, Doppler, Renal Angiogram, Abnormal captopril renal scan
- •evidence of renal insufficiency with serum creatinine >= 1.3 mg/dL
- •presence of two kidneys
- •willingness to provide written informed consent
- •Exclusion Criteria:
- •revascularization of stenotic renal artery
- •decompensated heart failure (subjects must be on stable medical therapy for one month)
- •any previous renal transplant (subjects may be on renal transplant waiting list)
- •history of liver disease
- •pregnant females
研究组 & 干预措施
1
Normal volunteers
干预措施: 62Cu-ethylglyoxal bis(thiosemicarbazone) (Drug)
1
Normal volunteers
干预措施: 15O-water (Drug)
1
Normal volunteers
干预措施: Positron Emission Tomography (Procedure)
2
Renal failure patients on dialysis
干预措施: 62Cu-ethylglyoxal bis(thiosemicarbazone) (Drug)
2
Renal failure patients on dialysis
干预措施: 15O-water (Drug)
2
Renal failure patients on dialysis
干预措施: Positron Emission Tomography (Procedure)
3
Renal artery stenosis patients
干预措施: 62Cu-ethylglyoxal bis(thiosemicarbazone) (Drug)
3
Renal artery stenosis patients
干预措施: 15O-water (Drug)
3
Renal artery stenosis patients
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Obtain preliminary information on efficacy for quantification of regional renal perfusion in two target clinical populations with a full range of renal disease using 150-water PET and 62Cu-ETS PET
时间窗: one day
次要结局
- Assess the safety of the drug 62Cu-ETS through expansion to two target patient populations and increase the size of the normal subjects group(one day)
研究者
Jeffrey L. Lacy
President
Proportional Technologies, Inc.