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

NCT00936416 | Completed

• 1 other identifier: UHN09-0096B
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Glomerular Filtration Rate; Renal Blood Flow; MRI; Inulin; Para-Aminohippuric Acid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

GFR and RBF followed by MRI

EXPERIMENTAL

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

Interventions

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.

GFR and RBF followed by MRI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Interventions

Inulin; Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Kartik Jhaveri, M.D.

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 10, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

CA (1)