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Multi-Parametric MRI for Renal Transplantation

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ClinicalTrials.gov Identifier: NCT03192007
Recruitment Status : Not yet recruiting
First Posted : June 19, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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 CMRR: the 3T scanner and the 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.


Condition or disease Intervention/treatment
Renal Transplant Rejection 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.


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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Parametric MRI for Renal Transplantation
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: MRI




Primary Outcome Measures :
  1. Anatomic and functional MRI characteristics in transplant kidneys with stable renal function [ Time Frame: Baseline ]
    Investigate the correlations between anatomic and functional characteristics by MRI and the level of transplant renal function


Secondary Outcome Measures :
  1. Anatomic and functional MRI characteristics of transplant kidneys with transplant complications [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192007


Locations
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United States, Minnesota
CMMR Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03192007     History of Changes
Other Study ID Numbers: 1610M96261
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No