This pilot clinical trial studies magnetic resonance imaging (MRI) with gadoxetate disodium in measuring tumors in patients with liver cancer. Diagnostic procedures, such as MRI with gadoxetate disodium, may help find and diagnose liver cancer and find out how far the disease has spread. It is not yet known whether MRI with gadoxetate disodium provides a more precise measurement of liver tumors than standard computed tomography (CT).
PRIMARY OBJECTIVES: I. To evaluate the precision of gadoxetate (gadoxetate disodium)-enhanced MRI in evaluating lesion size. II. To evaluate if there is a subjective improvement in the delineation of hepatocellular carcinoma (HCC) in the hepatocellular phase of contrast administration. III. To further assess the sensitivity of gadoxetate-enhanced MRI for the detection of HCC. SECONDARY OBJECTIVES: I. To evaluate the reproducibility of various tumor measurement techniques in the evaluation of HCC. II. To further evaluate how administration of gadoxetate affects diffusion weighted imaging. OUTLINE: Patients receive gadoxetate disodium intravenously (IV) and then undergo enhanced liver MRI. After completion of study, patients are followed up at 2, 4, 8, and 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
26
Given IV
Undergo MRI with gadoxetate disodium
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Precision in tumor measurement for each type of image (CT vs. MRI), for each phase ( 4 for CT and 5 for MRI), and for each method of measuring "size" (1-,2-, and 3-dimensional), assessed by low inter- and intra-reader variability
Initially, a random effects analysis of variance (ANOVA) will be performed for each type of image (CT vs. MRI), for each phase (4 for CT and 5 for MRI) and for each method of measuring "size" (1-, 2-, and 3-dimensional) - for a total of 27 ANOVAs. Lesion, radiologist, and replication (for the 20 target lesions measured twice) will all be random effects; the inter-reader and the intra-reader variability will be estimated from these models and 95% confidence intervals will be constructed.
Time frame: Up to 24 hours
Changes in apparent diffusion coefficient (ADC) values within lesions and within normal liver before and after administration of Gadoxetate
ADC values will be recorded for uninvolved liver parenchyma and for tumors before and after administration of gadoxetate disodium.
Time frame: Up to 24 hours
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