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

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Renal Physiology (Glomerular Filtration Rate and Blood Flow) by MRI With Validation by Inulin and Para-Aminohippuric Acid Clearance in Normal Volunteers

Conditions
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Glomerular Filtration Rate, Renal Blood Flow

Intervention / Treatment
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* Procedure: Inulin and PAH clearance and MRI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GFR and RBF followed by MRI<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glomerular Filtration Rate, Renal Blood Flow, MRI, Inulin, Para-Aminohippuric Acid