Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)

NCT ID: NCT03918161

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-24
• Study Completion Date: 2020-12-12

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.

Conditions

Interstitial Fibrosis/Tubular Atrophy of Transplanted Kidneys

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MRE exam

Magnetic Resonance Elastography (MRE) exam associated with standard T1-weighted and T2-weighted sequences

Group Type: EXPERIMENTAL

MRE exam

Intervention Type: DEVICE

Magnetic Resonance Elastography

Interventions

MRE exam

Magnetic Resonance Elastography

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2019/17

Identifier Type: -

Identifier Source: org_study_id