Multi-Parametric MRI for Renal Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnetic Resonance Imaging.
- Who it may be relevant to
- Registry conditions: Renal Transplant Rejection. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The goals of this study are: * To optimize and evaluate multiple kidney MRI methods; and * To investigate the potential of MRI in the assessment of transplant kidney functions; To achieve these goals, we will perform pilot MRI studies with kidney transplant patients. We will study if MRI can reflect different levels of kidney function. The investigators will also evaluate if MRI can differentiate causes for declining kidney function. Finally, the investigators will explore how MRI measures changes before and after medical treatment for worsening kidney function. You may be invited for MRI exams with different exam options. An MRI exam may use either of two types of MRI machines at the center for magnetic resonance research (CMRR): the 3 Tesla (3T) scanner and the 7 Tesla (7T) scanner. You may also be invited for a multi-session exam. A description of the MRI exam types with different exam options and the types of multi-session exams is provided later in this document.
Detailed description
To achieve these goals, the investigators will perform pilot MRI studies with kidney transplant patients. The investigators will study if MRI can reflect different levels of kidney function. The investigators will also evaluate if MRI can differentiate causes for declining kidney function. Finally, the investigators will explore how MRI measures changes before and after medical treatment for worsening kidney function.
Subjects may be invited for MRI exams with different exam options. An MRI exam may use either of two types of MRI machines at the CMRR: the 3T scanner and the 7T scanner. Subjects may also be invited for a multi-session exam. A description of the MRI exam types with different exam options and the types of multi-session exams is provided later in this document.
Interventions
- Device Magnetic Resonance Imaging
Investigate anatomic and functional characteristics of transplant kidneys using MRI
Primary outcome measures
- Anatomic and functional MRI characteristics in transplant kidneys with stable renal function [Time frame: Baseline]
Secondary outcome measures (1)
- Anatomic and functional MRI characteristics of transplant kidneys with transplant complications [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Renal Transplant Recipients
- Capable to consent
- English speaking
- For studies with patients with fast worsening renal function: An abrupt (within 48 h) reduction in kidney function currently defined as a percentage increase in serum creatinine of ≥50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria of less than 0.5 mL/kg/h for more than 6 h).
- For patients with recovered renal allograft function after therapy: renal allograft function as measured by glomerular filtration rate (eGRF) has been recovered and stabilized above a clinical acceptable level, such as 15 ml/min/1.73 mm2.
Exclusion criteria
- On dialysis due to renal allograft failure
- Acute and chronic pulmonary disease
- Pregnancy as reported in CMRR Safety Screen
- Ferromagnetic implants
- Any foreign metal objects in the body
- History of shrapnel or shot gun injury
- Cardiac pacemakers
- Defibrillator
- Neuronal stimulator
- Magnetic aneurysm clip
- Large tattoos on the abdomen or the brain and neck, as determined by CMRR Safety Officer
- Hip replacement
- Too large to fit in the magnet (BMI >= 40, approx.)
- Severe claustrophobia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- CMMR — Minneapolis
Identifiers
NCT: NCT03192007 · 1610M96261