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Assessment of Renal Physiology by Magnetic Resonance Imaging (MRI) in Normal Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936416
First Posted: July 10, 2009
Last Update Posted: January 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Health Network, Toronto
  Purpose

Estimation of Glomerular Filtration Rate (GFR) is the primary test used to assess patients with renal disease. Although serum creatinine based GFR and nuclear medicine based estimations are routinely used in clinical practice, GFR estimation by Inulin is the recommended gold standard. Inulin based estimation of GFR is cumbersome and time consuming.

A decrease in blood flow to the kidney (Renal Blood Flow (RBF)) is known to cause a decrease in GFR. RBF is typically determined using radioactive tracers, contrast MRI or a cumbersome para-aminohippuric acid (PAH) clearance method.

MRI based assessment of GFR and RBF have been suggested to provide reasonable accuracy. Most of these studies did not compare the GFR and RBF estimation directly to Inulin and PAH clearance which are ther gold standards . In this study we propose to estimate MRI based GFR estimation directly to Inulin and noncontrast MRI based derived RBF to PAH to assess if MRI is an accurate test of kidney function.


Condition Intervention
Glomerular Filtration Rate Renal Blood Flow Procedure: Inulin and PAH clearance and MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Assessment of Renal Physiology (Glomerular Filtration Rate and Blood Flow) by MRI With Validation by Inulin and Para-Aminohippuric Acid Clearance in Normal Volunteers

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • GFR estimation comparison between results obtained by MRI and Inulin clearance method. Blood flow estimation comparison between results obtained by MRI and PAH clearance method. [ Time Frame: 1 year ]

Enrollment: 24
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GFR and RBF followed by MRI
Subjects will undergo GFR and renal blood flow estimation by Inulin and PAH clearance method, followed by a MRI test. The MRI examination will be performed on the same day as the inulin/PAH procedure.
Procedure: Inulin and PAH clearance and MRI

GFR and renal blood flow estimation by Inulin and PAH clearance will be performed in the Renal Physiology Lab for approximately 2.5 hours;

The MRI test will be performed afterwards at Medical Imaging department and last about 45 minutes.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female volunteers with no known renal disease
  • Ages between 18-65 years
  • Normal routine urinalysis
  • Estimated GFR (eGFR) >=90mls/min
  • Arterial pressure < 130/85
  • No medications (birth control pills and vitamins are acceptable)

Exclusion Criteria:

  • Pregnancy
  • Age <18y or >65y
  • Proteinuria or hematuria as determined by routine urinalysis
  • Estimate GFR (eGFR) < 90 ml/min
  • Known history or requirement of treatment for hypertension
  • Known allergy to inulin or PAH
  • MRI contrast allergy, general contraindications to MRI such as pacemaker, etc.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936416


Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Kartik Jhaveri, M.D. University Health Network, Toronto
  More Information

Responsible Party: Kartik Jhaveri, MD/Principal Investigator, University Health Network
ClinicalTrials.gov Identifier: NCT00936416     History of Changes
Other Study ID Numbers: UHN09-0096B
First Submitted: July 8, 2009
First Posted: July 10, 2009
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by University Health Network, Toronto:
Glomerular Filtration Rate
Renal Blood Flow
MRI
Inulin
Para-Aminohippuric Acid