Advanced Adult Hepatocellular Carcinoma Clinical Trial
Official title:
MR Techniques in the Evaluation of Hepatocellular Carcinoma: Gadoxetate
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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