Renal Magnetic Resonance (MR) Elastography in Healthy Volunteers (MRE_Rénale)

This study has been completed.
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00876629
First received: March 10, 2009
Last updated: August 18, 2009
Last verified: August 2009
  Purpose

MR Elastography is a new technique aimed at non-invasively measuring the stiffness of tissues. It has recently given interesting results in the assessment of liver fibrosis.

The objectives of the current study are:

  1. to develop an imaging protocol for MR Elastography of the kidneys;
  2. To calculate the stiffness of normal kidneys;
  3. To evaluate the variability of the measurements of kidney stiffness by repeating the procedure twice on the same volunteers.

Condition Intervention
Healthy
Device: Pneumatic Driver

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Renal MR Elastography: Normal Findings and Variability of Stiffness Measurements

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Normal kidney stiffness (measured from MRE data) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Variability of stiffness measurement (on repeat examination) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerance of the procedure [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Percentage of partial and total technical failures [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Quality criteria of stiffness measurements (area of the ROIs used for measurement, mean induced displacement measured in the ROIs) [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: March 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Pneumatic Driver

    Ten healthy volunteers will undergo MR Elastography using a pneumatic driver connected to a commercially available speaker and the stiffness of the left kidney will be measured.

    The examination will be repeated on the same volunteers at least one month later and the same stiffness measurements will be performed.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 18 and 40
  • Signed informed consent form
  • Insured by the French Social Security

Exclusion Criteria:

  • Pregnancy
  • Personal or familial history of kidney disease
  • Hypertension
  • Diabetes
  • Contraindication to MRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876629

Locations
France
Department of Urinary an Vascular Radiology, Hôpital E. Herriot
Lyon, France, 69437
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Olivier Rouvière, MD Hôpital E. Herriot
  More Information

No publications provided

Responsible Party: Pr Olivier Rouvière, Hôpital E. Herriot
ClinicalTrials.gov Identifier: NCT00876629     History of Changes
Other Study ID Numbers: 2008.529
Study First Received: March 10, 2009
Last Updated: August 18, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
MR Elastography
kidney
fibrosis

ClinicalTrials.gov processed this record on July 23, 2014