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

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.

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Key information

Conditions

Glomerular Filtration Rate Renal Blood Flow

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inulin and PAH clearance and MRI

Procedure

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jul 10, 2009
Registry last updated: Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed