Renal Magnetic Resonance (MR) Elastography in Healthy Volunteers (MRE_Rénale)
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:
- to develop an imaging protocol for MR Elastography of the kidneys;
- To calculate the stiffness of normal kidneys;
- To evaluate the variability of the measurements of kidney stiffness by repeating the procedure twice on the same volunteers.
|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|
- 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 ]
- 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 ]
|Study Start Date:||March 2009|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876629
|Department of Urinary an Vascular Radiology, Hôpital E. Herriot|
|Lyon, France, 69437|
|Principal Investigator:||Olivier Rouvière, MD||Hôpital E. Herriot|