Multi-Parametric MRI for Renal Transplantation

NCT ID: NCT03192007

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2027-07-01

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Renal Transplant Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Stable Renal Function

Patients will be given MRI

Magnetic Resonance Imaging

Intervention Type DEVICE

Investigate anatomic and functional characteristics of transplant kidneys using MRI

Patients with Worsening Renal Function due to complications

MRI

Magnetic Resonance Imaging

Intervention Type DEVICE

Investigate anatomic and functional characteristics of transplant kidneys using MRI

Interventions

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Magnetic Resonance Imaging

Investigate anatomic and functional characteristics of transplant kidneys using MRI

Intervention Type DEVICE

Other Intervention Names

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MRI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CMMR

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1610M96261

Identifier Type: -

Identifier Source: org_study_id

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