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Renal Blood Flow Measurement With Positron Emission Tomography (PET)

Primary Purpose

Renal Failure, Renal Artery Stenosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

62Cu-ethylglyoxal bis(thiosemicarbazone)

15O-water

Positron Emission Tomography

About this trial

This is an interventional diagnostic trial for Renal Failure focused on measuring Renal blood flow, PET imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Wisconsin - Madison

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

Normal volunteers

Renal failure patients on dialysis

Renal artery stenosis patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assess the safety of the drug 62Cu-ETS through expansion to two target patient populations and increase the size of the normal subjects group

Full Information

NCT ID

NCT00714142

First Posted

July 10, 2008

Last Updated

April 17, 2017

Sponsor

Jeffrey L. Lacy

Collaborators

University of Wisconsin, Madison

1. Study Identification

Unique Protocol Identification Number

NCT00714142

Brief Title

Renal Blood Flow Measurement With Positron Emission Tomography (PET)

Official Title

Renal Blood Flow Measurement With PET

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jeffrey L. Lacy

Collaborators

University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Failure, Renal Artery Stenosis

Keywords

Renal blood flow, PET imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Normal volunteers

Arm Title

Arm Type

Active Comparator

Arm Description

Renal failure patients on dialysis

Arm Title

Arm Type

Active Comparator

Arm Description

Renal artery stenosis patients

Intervention Type

Drug

Intervention Name(s)

62Cu-ethylglyoxal bis(thiosemicarbazone)

Intervention Description

15-25 mCi, IV

Intervention Type

Drug

Intervention Name(s)

15O-water

Intervention Description

10-20 mCi, IV

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography

Intervention Description

PET Scan

Primary Outcome Measure Information:

Title

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

Time Frame

one day

Secondary Outcome Measure Information:

Title

Assess the safety of the drug 62Cu-ETS through expansion to two target patient populations and increase the size of the normal subjects group

Time Frame

one day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey L Lacy, PhD

Organizational Affiliation

Proportional Technologies, Inc.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Charles K Stone, MD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin - Madison

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

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Renal Blood Flow Measurement With Positron Emission Tomography (PET)

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