Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Bile Duct Diseases

Liver Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Biliary Tract Diseases

Primary Liver Cancer

Hematinics

All Drugs and Chemicals

Anticoagulants

Micronutrients

Bone Density Conservation Agents

Liver Extracts

Edetic Acid

Pentetic Acid

Antidotes

Protective Agents

Chelating Agents

Iron

Iron Chelating Agents

Calcium

Calcium, Dietary

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.

Contrast-enhanced Magnetic Resonance Imaging

Gadobutrol

Gadoxetate Disodium

Janio Szklaruk, MD, PHD

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.

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.

Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

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

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions	NCT02156739	Hepatocellular ... Liver and Intra... Metastatic Mali... Primary Maligna...	Contrast-enhanc... Gadobutrol Gadoxetate Diso...	18 Years -	M.D. Anderson Cancer Center
Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions	NCT02156739	Hepatocellular ... Liver and Intra... Metastatic Mali... Primary Maligna...	Contrast-enhanc... Gadobutrol Gadoxetate Diso...	18 Years -	M.D. Anderson Cancer Center
Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions	NCT02156739	Hepatocellular ... Liver and Intra... Metastatic Mali... Primary Maligna...	Contrast-enhanc... Gadobutrol Gadoxetate Diso...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for liver and intrahepatic bile duct disorder