Evaluation of Gadoterate in Patients With Decreased Kidney Function

Phase 4

• Conditions: Renal Dysfunction
• Interventions: Other: No Gadoterate; Drug: Gadoterate

• Registration Number: NCT02382380
• Lead Sponsor: Loyola University

Brief Summary

This study is for individuals with decreased kidney function whose doctor has ordered Magnetic Resonance Imaging (MRI). Because kidney function is decreased, these patients usually do not receive the intravenous contrast material that can improve the accuracy of the MRI findings. The purpose of this study is to evaluate the safety and benefit of using a contrast material called Gadoterate in patients with decreased kidney function.

Detailed Description

Gadolinium-based intravenous contrast agents are widely used for the enhancement of MRI findings. However, these agents have been implicated in varying degrees of nephrotoxicity and therefore are not usually used in patients with renal dysfunction. Gadoterate is a Gadolinium agent and previous studies have indicated that it is safe in patients with decreased kidney function. The purpose of this study is to evaluate the safety and efficacy of using Gadoterate in this patient population.

Participants who have been scheduled for an MRI will choose to either receive Gadoterate contrast as part of their MRI or not receive Gadoterate as part of their MRI.

Study Timeline

• Study First Submitted: 2015-02-27
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-06
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-07
• Primary Completion: 2019-10
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Glomerular filtration rates (GFR) less than 30 ml/min but not on dialysis
• Being sent for an MRI examination in the course of routine clinical evaluation of one of the following indications: suspected or known head/neck/brain mass, hepatic mass, renal mass, pancreatic mass, or prostate mass, as well as evaluation of carotid or abdominopelvic vasculature.

Exclusion Criteria

• Pregnant and lactating females
• Planned initiation of chemotherapy or surgery within 72 hours of the MRI exam
• Hemodynamic instability or acute coronary syndrome
• History of nephrotoxic medication within 2 weeks of the exam
• Less than 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Gadoterate	No Gadoterate	Patients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. MRI protocols utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
Gadoterate	Gadoterate	Patients who choose to receive Gadoterate will receive an MRI exam with standard pre-contrast and Gadoterate-enhanced acquisitions (0.2 mL/kg). The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).

Primary Outcome Measures

Name	Time	Method
Change in glomerular filtration rate (GFR)	6 months	Change in GFR from 0 to 6 months

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States