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Completed

NCT Number: NCT00876629

Renal Magnetic Resonance (MR) Elastography in Healthy Volunteers

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.

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Key information

Conditions

Healthy Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urinary an Vascular Radiology, Hôpital E. Herriot

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumatic Driver

Device

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.

Primary outcomes

  1. Normal kidney stiffness (measured from MRE data)

    Time frame: 2 months

  2. Variability of stiffness measurement (on repeat examination)

    Time frame: 2 months

Secondary outcomes

  1. Tolerance of the procedure

    Time frame: 2 months

  2. Percentage of partial and total technical failures

    Time frame: 2 months

  3. Quality criteria of stiffness measurements (area of the ROIs used for measurement, mean induced displacement measured in the ROIs)

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Renal MR Elastography: Normal Findings and Variability of Stiffness Measurements

Acronym: MRE_Rénale

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 7, 2009
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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