Renal Failure, Renal Artery Stenosis
Conditions
Keywords
Renal blood flow, PET imaging
Brief summary
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.
Interventions
DRUG62Cu-ethylglyoxal bis(thiosemicarbazone)
15-25 mCi, IV
DRUG15O-water
10-20 mCi, IV
PROCEDUREPositron Emission Tomography
PET Scan
Sponsors
University of Wisconsin, Madison
Jeffrey L. Lacy
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Arm 1. Inclusion Criteria: * males and females, age 18-40 years * willingness to provide written informed consent
Exclusion criteria
* 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 Arm 2. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | one day |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed