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

NCT ID: NCT00936416

Last Updated: 2012-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-12-31

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.

Conditions

Glomerular Filtration Rate; Renal Blood Flow

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Inulin and PAH clearance and MRI

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

University Health Network

Principal Investigators

Kartik Jhaveri, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN09-0096B

Identifier Type: -

Identifier Source: org_study_id