Evaluation of Gadoterate in Patients With Decreased Kidney Function

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Collaborator: Guerbet
• Treatments: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate; Pancrelipase

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