COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03918161
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

: GREFFE_ELASTO IRM will evaluate Magnetic Resonance Elastography (MRE) in renal transplant patients with suspected interstitial fibrosis/tubular atrophy lesions requiring biopsy graft sampling under ultrasound control.

The main objective is to search a correlation between renal graft parenchymal elasticity values obtained in vivo by MRE, and the histological data of renal fibrosis by biopsy sampling, and providing a non-invasive tool capable of detecting and monitoring this development over time, making possible in the future to reduce the number of renal biopsies.


Condition or disease Intervention/treatment Phase
Interstitial Fibrosis/Tubular Atrophy of Transplanted Kidneys Device: MRE exam Not Applicable

Detailed Description:

The natural history of interstitial fibrosis/tubular atrophy (IF/TA) is a common mechanism of disease progression of transplanted kidneys. The process has been well studied through protocol biopsies. The early phase is characterized by fibrogenesis and the emergence of tubulo-interstitial damage due to immunologic phenomena; the late phase is characterized by the worsening of parenchymal lesions and the occurrence of glomerular sclerosis leading to graft loss.

Today, non-invasive markers of these pathological changes are missing and the protocol biopsies are still the only reliable tool for the diagnosis of IF/TA.

Elasticity imaging has already been proven in the management of chronic liver diseases with Fibroscan. In the field of renal diseases, several studies have been carried out in ultrasound elastography on renal grafts but the renal elastography is more difficult due to the complexity of the kidney (deep organ, two compartments, high vascularity). All these parameters have an influence on the elasticity measures.

The elastography imaging is also performed in MRI (Magnetic resonance imaging): The Magnetic Resonance Elastography (MRE). MRE is less subject to variations in depth, to the experience of the operator and to allow an overall evaluation of the graft.

The potentially eligible patients will be recruited by the nephrologist during a consultation in which renal biopsy is scheduled (as part of current practice). Patients meeting the inclusion criteria and having no exclusion criteria will be offered to participate in this study. If accepted, the only examination specific to this research, the MRE, will be scheduled to be performed the same day as the renal biopsy.

This MRE is painless, non-irradiating, and does not require the injection of contrast medium.

The participation of the patient ends when he leaves the hospital after the biopsy procedure.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients will realize Magnetic Resonance Elastography exam
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)
Actual Study Start Date : July 24, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: MRE exam
Magnetic Resonance Elastography (MRE) exam associated with standard T1-weighted and T2-weighted sequences
 Device: MRE exam
Magnetic Resonance Elastography


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mean value of renal elasticity [ Time Frame: Baseline (defined as during MRE exam) ]
    5 times' measures in comparison with the upper pole of the graft which corresponds to the biopsy site (unit kilo-Pascal)


Secondary Outcome Measures :
  1. Average value of renal elasticity [ Time Frame: Baseline (defined as during MRE exam) ]
    measured in 10 areas of the graft Intra-renal inflammation, tubulitis, chronic vascular and glomerular lesions measured semi-quantitatively by the pathologist following the Banff classification


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18yrs;
  • Transplanted kidney patient with suspicion of IF/TA lesions requiring biopsy graft sampling under ultrasound control;
  • Signed informed consent;
  • Affiliated or beneficiary of health insurance

Exclusion Criteria:

  • Patients with dilated pyelocaliceal cavities on ultrasound or significant renal artery stenosis (> 80%) on Doppler;
  • Pregnant or nursing women;
  • Contraindications to MRI;
  • Person deprived of liberty, major who is the subject of a legal protection measure or unable to express consent
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT03918161


Contacts
Layout table for location contacts
Contact: Nicolas GRENIER, MS, PhD +335 56 79 55 99 nicolas.grenier@chu-bordeaux.fr
Contact: Lionel COUZI, MS, PhD ionel.couzi@chu-bordeaux.fr

Locations
Layout table for location information
France
CHU Bordeaux Recruiting
Bordeaux, France
Contact: Nicolas GRENIER, MD, PhD    +335 56 79 55 99    nicolas.grenier@chu-bordeaux.fr   
Contact: Lionel COUZI, MD, PhD    +335 56 79 55 38    lionel.couzi@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03918161    
Other Study ID Numbers: CHUBX 2019/17
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Interstitial fibrosis
Tubular atrophy Renal transplantation
Renal allograft
 Magnetic Resonance Imaging
Elastography
non-invasive diagnosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibrosis
Atrophy
Pathologic Processes
Pathological Conditions, Anatomical