HealthyMRE_RénaleNCT00876629
Renal Magnetic Resonance (MR) Elastography in Healthy Volunteers
A study testing Pneumatic Driver in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pneumatic Driver
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40
- Signed informed consent form
- Insured by the French Social Security
Who cannot join
- Pregnancy
- Personal or familial history of kidney disease
- Hypertension
- Diabetes
- Contraindication to MRI
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Urinary an Vascular Radiology, Hôpital E. Herriot
Lyon, 69437
About this study
Official title: 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:
- 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.
- Conditions
- Healthy
- Being tested
- Pneumatic Driver
- Keywords
- MR Elastography, kidney, fibrosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic DriverDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal kidney stiffness (measured from MRE data)
Measured: 2 months
Variability of stiffness measurement (on repeat examination)
Measured: 2 months
Secondary outcomes (3)
Tolerance of the procedure
Measured: 2 months
Percentage of partial and total technical failures
Measured: 2 months
Quality criteria of stiffness measurements (area of the ROIs used for measurement, mean induced displacement measured in the ROIs)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Olivier Rouvière, MD, Principal investigator, Hôpital E. Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876629
- Sponsor's protocol ID
- 2008.529
- Acronym
- MRE_Rénale
- Status last verified
- Aug 2009
- First submitted
- 10 Mar 2009
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21769970
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal MR Elastography: Normal Findings and Variability of Stiffness Measurements
- ClinicalTrials.gov ID
- NCT00876629
- Acronym / sponsor ID
- MRE_Rénale / 2008.529
- Conditions
- Healthy
- Keywords
- MR Elastography, kidney, fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 40
- Signed informed consent form
- Insured by the French Social Security
Key exclusion criteria (5 listed)
- Pregnancy
- Personal or familial history of kidney disease
- Hypertension
- Diabetes
- Contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumatic DriverTen 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. | Device | – |
Primary outcome
Normal kidney stiffness (measured from MRE data)
Time frame: 2 months
Variability of stiffness measurement (on repeat examination)
Time frame: 2 months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Results publication: PubMed 21769970Rouviere 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Rouvière, MD principal investigator
Hôpital E. Herriot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumatic Driver in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal kidney stiffness (measured from MRE data) (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.