Multi-Parametric MRI for Renal Transplantation

NCT03192007 | Not Yet Recruiting FDA Device

• 1 other identifier: 1610M96261
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anatomic and functional MRI characteristics of transplant kidneys with transplant complications

  Baseline

Study Arms (2)

Patients with Stable Renal Function

Patients will be given MRI

Device: Magnetic Resonance Imaging

Patients with Worsening Renal Function due to complications

MRI

Device: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging DEVICE

Investigate anatomic and functional characteristics of transplant kidneys using MRI

Also known as: MRI

Patients with Stable Renal Function; Patients with Worsening Renal Function due to complications

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

CMMR

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: June 19, 2017
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)