Renal Blood Flow Measurement With Positron Emission Tomography (PET)

Study Overview
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Brief Summary
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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.

Official Title
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Renal Blood Flow Measurement With PET

Conditions
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Renal Failure, Renal Artery Stenosis

Intervention / Treatment
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* Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)
* Drug: 15O-water
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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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 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 Arm 3. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Normal volunteers | Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)<br>* 15-25 mCi, IV<br>Drug: 15O-water<br>* 10-20 mCi, IV<br>Procedure: Positron Emission Tomography<br>* PET Scan<br>|
| Active Comparator: 2<br>Renal failure patients on dialysis | Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)<br>* 15-25 mCi, IV<br>Drug: 15O-water<br>* 10-20 mCi, IV<br>Procedure: Positron Emission Tomography<br>* PET Scan<br>|
| Active Comparator: 3<br>Renal artery stenosis patients | Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)<br>* 15-25 mCi, IV<br>Drug: 15O-water<br>* 10-20 mCi, IV<br>Procedure: Positron Emission Tomography<br>* PET Scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal blood flow, PET imaging