Multi-Parametric MRI for Renal Transplantation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Transplant Rejection
• Intervention / Treatment: Device: Magnetic Resonance Imaging

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.

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • CMMR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The proposed studies are pilot studies to obtain preliminary data for the development of hypotheses and estimate the power for future large-scale studies. To accomplish the objectives of the proposed pilot studies, we will enroll a total of 140 renal transplant patients. Based on our previous experience, there will be about 20% patients who may withdraw after informed consent. Equal number of male and female subjects will be recruited for each patient group. In addition, the age of patients will be matched or ensured insignificant across the groups of the study objectives.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Stable Renal Function; Patients will be given MRI	Device: Magnetic Resonance Imaging; Investigate anatomic and functional characteristics of transplant kidneys using MRI; Other Names: MRI
Patients with Worsening Renal Function due to complications; MRI	Device: Magnetic Resonance Imaging; Investigate anatomic and functional characteristics of transplant kidneys using MRI; Other Names: MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomic and functional MRI characteristics in transplant kidneys with stable renal function	Investigate the correlations between anatomic and functional characteristics by MRI and the level of transplant renal function	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomic and functional MRI characteristics of transplant kidneys with transplant complications	Investigate the anatomic and functional MRI characteristics of transplant kidneys with transplant complications with comparisons with those from transplant kidneys having stable renal function	Baseline

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1610M96261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No