Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Contrast-enhanced Magnetic Resonance Imaging
* Drug: Gadobutrol
* Drug: Gadoxetate Disodium


Participation Criteria
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Eligibility Criteria
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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

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (contrast-enhanced MRI)<br>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. | Procedure: Contrast-enhanced Magnetic Resonance Imaging<br>* Undergo contrast-enhanced MRI<br>* Other names: Contrast-enhanced MRI;Drug: Gadobutrol<br>* Given IV<br>* Other names: ZK 135079;Drug: Gadoxetate Disodium<br>* Given IV<br>* Other names: ZK 139834;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI) | Summary statistics of sensitivity, specificity, true positives, true negatives, false positives, and false negatives will be provided for gadoxetate disodium and gadoxetate disodium + gadobutrol method. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value will be estimated along with corresponding 95% confidence intervals for the two methods. Comparison between the two methods will be made following method by Obuchowski. Other statistical analyses will be carried out as appropriate. | Up to 4 years |