Renal Blood Flow Measurement With Positron Emission Tomography (PET)

Renal Blood Flow Measurement With PET

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.

Study Overview

• Status: Completed
• Conditions: Renal Failure; Renal Artery Stenosis
• Intervention / Treatment: Procedure: Positron Emission Tomography; Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone); Drug: 15O-water

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Jeffrey L. Lacy
• Collaborators: University of Wisconsin, Madison
• Investigators: Principal Investigator: Jeffrey L Lacy, PhD, Proportional Technologies, Inc.; Principal Investigator: Charles K Stone, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: July 10, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 14, 2008

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: PET imaging; Renal blood flow
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Renal Artery Obstruction
• Other Study ID Numbers: UW HS IRB 2008-0097; DK58466