Renal Blood Flow Measurement With Positron Emission Tomography (PET)

NCT00714142 | Completed Phase 2 DMC

• 2 other identifiers: UW HS IRB 2008-0097DK58466
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure; Renal Artery Stenosis

Keywords

Renal blood flow; PET imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

1

ACTIVE COMPARATOR

Normal volunteers

Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone); Drug: 15O-water; Procedure: Positron Emission Tomography

2

ACTIVE COMPARATOR

Renal failure patients on dialysis

Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone); Drug: 15O-water; Procedure: Positron Emission Tomography

3

ACTIVE COMPARATOR

Renal artery stenosis patients

Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone); Drug: 15O-water; Procedure: Positron Emission Tomography

Interventions

62Cu-ethylglyoxal bis(thiosemicarbazone) DRUG

15-25 mCi, IV

1; 2; 3

15O-water DRUG

10-20 mCi, IV

1; 2; 3

Positron Emission Tomography PROCEDURE

PET Scan

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males and females, age 18-40 years
• willingness to provide written informed consent

You may not qualify if:

• 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.
• 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
• 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

Sponsors & Collaborators

• Jeffrey L. Lacy: lead
• University of Wisconsin, Madison: collaborator

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Renal Artery Obstruction

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jeffrey L Lacy, PhD

  Proportional Technologies, Inc.

  PRINCIPAL INVESTIGATOR

• Charles K Stone, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 14, 2008
• Study Start: August 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

US (1)