Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Metastatic Malignant Neoplasm in the Liver; Liver and Intrahepatic Bile Duct Disorder; Hepatocellular Carcinoma; Primary Malignant Liver Neoplasm

Treatments: Drug: Gadoxetate Disodium; Procedure: Contrast-enhanced Magnetic Resonance Imaging; Drug: Gadobutrol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02156739

2012-1157 (Other Identifier)

NCI-2014-02333 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with the most recent abdominal magnetic resonance (MR) study obtained within 3 months +/- 1 week
• Patients with renal function (estimated glomerular filtration rate [eGFR] >= 30)
• Any disease type

Exclusion criteria

• Pregnant women
• Patients with impaired renal function (eGFR < 30)
• Patients with surgical implants and/or metallic foreign bodies non-compatible with the MR magnet
• Patients with contraindications to the use of intravenous contrast such as allergic type reactions

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Diagnostic (contrast-enhanced MRI)

Experimental group

Description:

Patient receives each of these over one minute. For the gadoxetate disodium, dynamic imaging is performed immediately and imaging is performed at 20 minutes. For the gadobutrol, dynamic imaging is performed immediately.

Treatment:

Drug: Gadobutrol

Procedure: Contrast-enhanced Magnetic Resonance Imaging

Drug: Gadoxetate Disodium