Renal Magnetic Resonance (MR) Elastography in Healthy Volunteers (MRE_Rénale)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00876629|
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : August 19, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: Pneumatic Driver||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Renal MR Elastography: Normal Findings and Variability of Stiffness Measurements|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
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.
- Normal kidney stiffness (measured from MRE data) [ Time Frame: 2 months ]
- Variability of stiffness measurement (on repeat examination) [ Time Frame: 2 months ]
- Tolerance of the procedure [ Time Frame: 2 months ]
- Percentage of partial and total technical failures [ Time Frame: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876629
|Department of Urinary an Vascular Radiology, Hôpital E. Herriot|
|Lyon, France, 69437|
|Principal Investigator:||Olivier Rouvière, MD||Hôpital E. Herriot|