Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

Mayo Clinic22 enrolled

Overview

The purpose of this study is to validate an MRI method to detect renal fibrosis in patients after kidney transplantation (KT).

The hypothesis underlying this proposal is that qMT reliably detects development of allograft fibrosis in human subjects after KT. To test this hypothesis, the qMT-derived bound pool fraction will be correlated with renal fibrosis as per biopsy in 20 patients 4 or 7 years after living donor KT. The bound pool fraction will also be compared to renal blood flow, oxygenation, and function, and the ability of qMT to provide consistent assessments of fibrosis tested at different magnetic field strengths. Two specific aims will test the hypotheses that: Specific Aim 1: qMT provides reliable and consequential assessment of fibrosis in human kidney allografts. Specific Aim 2: Renal fibrosis assessed by qMT in human kidney allografts is reproducible at 1.5 T and 3.0 T.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Kidney Transplantation

Interventions

MRI 1.5T and 3.0TOTHER

Magnetic Resonance Imaging for Renal Fibrosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-80 years * Recipient of living donor kidney transplantation 4 or 7 years earlier * Competent and able to provide written informed consent; Ability to comply with protocol Exclusion Criteria: * Patients have clinically significant medical conditions within the prior 6 months before: e.g. myocardial infarction, congestive heart failure, stroke, that would, in the opinion of the investigators, compromise the safety of the patient. * Severe chronic liver, heart or lung disease * Undergoing acute rejection * Contra-indication to biopsy; bleeding disorders * Chronic infection * Any active malignancy and undergoing therapy * Kidney or ureteric stone * Unable to give valid informed consent * Known pregnancy or intent to conceive during the study period * Pacemaker, implantable defibrillator, magnetically active metal fragments, claustrophobia or other contraindication to MRI * Federal medical center inmates. * Latex allergy

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

The values and correlation of f with IF

Correlation of qMT with tissue fibrosis (trichrome)

Time frame: 2 years

Secondary Outcomes

The correlation of f with renal function attributes and pro-fibrogenic activity

Correlation of qMT with renal oxygenation, GFR, levels of fibrogenic factors.

Time frame: 2 years

Data from ClinicalTrials.gov

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