Renal Blood Flow Measurement With Positron Emission Tomography (PET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Proportional Technologies, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by:
Proportional Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00714142
First received: July 10, 2008
Last updated: September 2, 2008
Last verified: September 2008
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Renal Blood Flow Measurement With PET

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: August 2008
Estimated Study Completion Date: April 2009
Estimated 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Jeffrey L Lacy, PhD 713-747-7324 ext 11 jlacy@proportionaltech.com

Locations
United States, Wisconsin
University of Wisconsin - Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Cassondra Vander Ark, RN, MS, CCRC    608-265-0612    cav@clinicaltrials.wisc.edu   
Principal Investigator: Charles K Stones, MD         
Sponsors and Collaborators
Proportional Technologies, Inc.
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

No publications provided

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: September 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by 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 October 19, 2014