Renal Magnetic Resonance (MR) Elastography in Healthy Volunteers
MRE_Rénale
Renal MR Elastography: Normal Findings and Variability of Stiffness Measurements
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Mar 2009
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 10, 2009
CompletedFirst Posted
Study publicly available on registry
April 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedMay 28, 2019
August 1, 2009
4 months
March 10, 2009
May 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Normal kidney stiffness (measured from MRE data)
2 months
Variability of stiffness measurement (on repeat examination)
2 months
Secondary Outcomes (3)
Tolerance of the procedure
2 months
Percentage of partial and total technical failures
2 months
Quality criteria of stiffness measurements (area of the ROIs used for measurement, mean induced displacement measured in the ROIs)
2 months
Interventions
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 Criteria
You may qualify if:
- Age between 18 and 40
- Signed informed consent form
- Insured by the French Social Security
You may not qualify if:
- Pregnancy
- Personal or familial history of kidney disease
- Hypertension
- Diabetes
- Contraindication to MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urinary an Vascular Radiology, Hôpital E. Herriot
Lyon, 69437, France
Related Publications (1)
Rouviere O, Souchon R, Pagnoux G, Menager JM, Chapelon JY. Magnetic resonance elastography of the kidneys: feasibility and reproducibility in young healthy adults. J Magn Reson Imaging. 2011 Oct;34(4):880-6. doi: 10.1002/jmri.22670. Epub 2011 Jul 18.
PMID: 21769970RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier Rouvière, MD
Hôpital E. Herriot
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 10, 2009
First Posted
April 7, 2009
Study Start
March 1, 2009
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
May 28, 2019
Record last verified: 2009-08