Renal Allograft : Evaluation of Parenchymal Fibrosis by Elastography (GREFE)

September 18, 2013 updated by: Hospices Civils de Lyon

Evaluation of the Potential of Elastography for Noninvasive Assessment of Fibrosis in Kidney Transplant

The purpose of this study is to assess the potential of elastography for noninvasive assessment of fibrosis in renal allograft.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69437
        • Recruiting
        • Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot
        • Contact:
        • Principal Investigator:
          • ROUVIERE Olivier, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Renal allograft performed less than 3 months before enrolment

Exclusion Criteria:

  • Contra-indication to magnetic resonance imaging
  • Contra-indication to biopsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnetic Resonance Elastography, Supersonic Shear Imaging
Magnetic Resonance Elastography and Supersonic Shear Imaging
Device: Magnetic Resonance Elastography, and Supersonic Shear Imaging
Magnetic Resonance Elastography, and Supersonic Shear Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between elasticity (as measured by elastography) and (a) Banff score for fibrosis, (b) glomerular filtration rate assessed by creatinine clearance, (c) glomerular filtration rate assessed by insulin clearance
Time Frame: 3 months and 12 months after graft
3 months and 12 months after graft

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of technical failures
Time Frame: 12 months
12 months
Tolerance (assessed by a questionnaire)
Time Frame: 3 months and 12 months after graft
3 months and 12 months after graft
Evolution of the elasticity of the transplant between 3 and 12 months after graft
Time Frame: 3 months and 12 months after graft
3 months and 12 months after graft
Correlation between elasticity and arterial resistance index
Time Frame: 3 months and 12 months after graft
3 months and 12 months after graft

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: ROUVIERE Olivier, Pr, Hospices Civils de Lyon Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot, 69437 Lyon Cedex 03

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

July 26, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Estimate)

September 19, 2013

Last Update Submitted That Met QC Criteria

September 18, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009.590

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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