Clinical trial NCT02382380: Evaluation of Gadoterate in Patients With Decreased Kidney Function
Official title: Evaluation of Gadoterate in Patients With Renal Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Renal Dysfunction
Keywords: Magnetic Resonance Imaging
Contrast Agent
Gadoterate
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2015-03-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in glomerular filtration rate (GFR)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University
name: Ari Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
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