Multi-Parametric MRI for Renal Transplantation

Renal Transplant Rejection Clinical Trial

Official title:

Multi-Parametric MRI for Renal Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03192007
• Other study ID #: 1610M96261
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Transplant Rejection

Intervention

Device:
• Magnetic Resonance Imaging
Investigate anatomic and functional characteristics of transplant kidneys using MRI

Locations

Country	Name	City	State
United States	CMMR	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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