Evaluation of Gadoterate in Patients With Decreased Kidney Function

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Gadoterate in Patients With Renal Dysfunction

Conditions
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Renal Dysfunction

Intervention / Treatment
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* Drug: Gadoterate
* Other: No Gadoterate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gadoterate<br>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). | Drug: Gadoterate<br>* 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).<br>* Other names: Dotarem;|
| Other: No Gadoterate<br>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). | Other: No Gadoterate<br>* Patients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glomerular filtration rate (GFR) | Change in GFR from 0 to 6 months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Resonance Imaging, Contrast Agent, Gadoterate