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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT00936416

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glomerular Filtration Rate Renal Blood Flow	Procedure: Inulin and PAH clearance and MRI	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

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. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00936416

Other Study ID Numbers:

UHN09-0096B

First Posted:

Jul 10, 2009

Last Update Posted:

Jan 18, 2012

Last Verified:

Jan 1, 2012

Keywords provided by , ,

Glomerular Filtration Rate

Renal Blood Flow

MRI

Inulin

Para-Aminohippuric Acid

Study Results

No Results Posted as of Jan 18, 2012