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Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)

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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

Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date April 29, 2020
Actual Study Start Date  ICMJE July 24, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)
Official Title  ICMJE Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Interstitial Fibrosis/Tubular Atrophy of Transplanted Kidneys
Intervention  ICMJE Device: MRE exam
Magnetic Resonance Elastography
Study Arms  ICMJE Experimental: MRE exam
Magnetic Resonance Elastography (MRE) exam associated with standard T1-weighted and T2-weighted sequences
Intervention: Device: MRE exam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03918161
Other Study ID Numbers  ICMJE CHUBX 2019/17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Bordeaux
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP