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Renal Blood Flow Measurement With Positron Emission Tomography (PET)

This study has been completed.
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Jeffrey L. Lacy, Proportional Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00714142
First received: July 10, 2008
Last updated: April 17, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Renal Failure Renal Artery Stenosis Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone) Drug: 15O-water Procedure: Positron Emission Tomography Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Renal Blood Flow Measurement With PET

Further study details as provided by Jeffrey L. Lacy, Proportional Technologies, Inc.:

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 [ Time Frame: one day ]

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 [ Time Frame: one day ]

Enrollment: 30
Study Start Date: August 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Normal volunteers
Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)
15-25 mCi, IV
Drug: 15O-water
10-20 mCi, IV
Procedure: Positron Emission Tomography
PET Scan
Active Comparator: 2
Renal failure patients on dialysis
Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)
15-25 mCi, IV
Drug: 15O-water
10-20 mCi, IV
Procedure: Positron Emission Tomography
PET Scan
Active Comparator: 3
Renal artery stenosis patients
Drug: 62Cu-ethylglyoxal bis(thiosemicarbazone)
15-25 mCi, IV
Drug: 15O-water
10-20 mCi, IV
Procedure: Positron Emission Tomography
PET Scan

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714142

Locations
United States, Wisconsin
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Jeffrey L. Lacy
University of Wisconsin, Madison
Investigators
Principal Investigator: Jeffrey L Lacy, PhD Proportional Technologies, Inc.
Principal Investigator: Charles K Stone, MD University of Wisconsin, Madison
  More Information

Responsible Party: Jeffrey L. Lacy, President, Proportional Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00714142     History of Changes
Other Study ID Numbers: UW HS IRB 2008-0097
DK58466
Study First Received: July 10, 2008
Last Updated: April 17, 2017

Keywords provided by Jeffrey L. Lacy, Proportional Technologies, Inc.:
Renal blood flow
PET imaging

Additional relevant MeSH terms:
Renal Insufficiency
Renal Artery Obstruction
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 16, 2017