Multi-Parametric MRI for Renal Transplantation

Not yet recruiting

• Conditions: Renal Transplant Rejection
• Interventions: Device: Magnetic Resonance Imaging

• Registration Number: NCT03192007
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Study Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Study Start: 2025-07-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Worsening Renal Function due to complications	Magnetic Resonance Imaging	MRI
Patients with Stable Renal Function	Magnetic Resonance Imaging	Patients will be given MRI

Primary Outcome Measures

Name	Time	Method
Anatomic and functional MRI characteristics in transplant kidneys with stable renal function	Baseline	Investigate the correlations between anatomic and functional characteristics by MRI and the level of transplant renal function

Secondary Outcome Measures

Name	Time	Method
Anatomic and functional MRI characteristics of transplant kidneys with transplant complications	Baseline	Investigate the anatomic and functional MRI characteristics of transplant kidneys with transplant complications with comparisons with those from transplant kidneys having stable renal function

Trial Locations

Locations (1)

CMMR; 🇺🇸 Minneapolis, Minnesota, United States