NCT02156739

Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced MRI

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.

Detailed description

PRIMARY OBJECTIVES: I. To compare the specificity of contrast enhanced MRI using a liver specific agent Eovist (gadoxetate disodium) versus the combined use of Eovist and an intravascular-extracellular agent Gadavist (gadobutrol) for the radiologic detection and characterization of liver lesions via clinical stability and follow up imaging. OUTLINE: Patients receive gadoxetate disodium intravenously (IV) over 1 minute and undergo MRI. Patients then receive gadobutrol IV over 1 minute at the 20 minute mark during MRI.

Conditions

• Hepatocellular Carcinoma
• Liver and Intrahepatic Bile Duct Disorder
• Metastatic Malignant Neoplasm in the Liver
• Primary Malignant Liver Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Contrast-enhanced Magnetic Resonance Imaging	Undergo contrast-enhanced MRI
DRUG	Gadobutrol	Given IV
DRUG	Gadoxetate Disodium	Given IV

Timeline

• Start date: 2014-10-13
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2014-06-05
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study