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

Not Applicable

Completed

• Conditions: Glomerular Filtration Rate; Renal Blood Flow
• Interventions: Procedure: Inulin and PAH clearance and MRI

• Registration Number: NCT00936416
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-09
• Study First Posted: 2009-07-10
• Study Start: 2010-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-13
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GFR and RBF followed by MRI	Inulin and PAH clearance and 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.

Primary Outcome Measures

Name	Time	Method
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.	1 year

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada