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

May 23, 2019 updated by: Hospices Civils de Lyon

Renal MR Elastography: Normal Findings and Variability of Stiffness Measurements

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69437
        • Department of Urinary an Vascular Radiology, Hôpital E. Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Normal kidney stiffness (measured from MRE data)
Time Frame: 2 months
2 months
Variability of stiffness measurement (on repeat examination)
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerance of the procedure
Time Frame: 2 months
2 months
Percentage of partial and total technical failures
Time Frame: 2 months
2 months
Quality criteria of stiffness measurements (area of the ROIs used for measurement, mean induced displacement measured in the ROIs)
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Olivier Rouvière, MD, Hôpital E. Herriot

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (Estimate)

April 7, 2009

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008.529

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Pneumatic Driver

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe