MRI With Gadoxetate Disodium in Measuring Tumors in Patients With Liver Cancer

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.

Inclusion Criteria:

- CT features suggestive of HCC, including those features which have been described
herein; they are also enumerated below:

- For an arterially-enhancing lesion greater than or equal to 1 cm, but under 2
cm, all of the following criteria must be met:

- Imaging features of a mass

- Wash-out on later phases of contrast administration

- At least 1 cm or more growth

- For an arterially-enhancing lesion greater than or equal to 2 cm, two of the
following criteria must be met:

- Imaging features of a mass

- Wash-out on later phases of contrast administration

- At least 1 cm or more growth

- All enhancing lesions with expansile, solid, enhancing tumor within vascular
structures will be included, including the main portal vein, the main right and
main left portal veins, the inferior vena cava (IVC), and the main hepatic veins

- No prior history of treatment of liver lesions

- Able to provide written and verbal informed consent

- Able to tolerate a complete abdominal MR examination, within 3 weeks of CT

Exclusion Criteria:

- Unable to provide written and verbal informed consent

- Unable to undergo MRI due to intraocular metallic foreign body, pacemaker, or other
contraindications including objects in the body which are deemed to be unsafe or
notable to be assessed, or unable to undergo MRI within 3 weeks of CT

- Pregnancy

- Severe renal insufficiency as defined by an estimated glomerular filtration rate of
less than 30 cc/minute

- Severe liver disease as defined by Childs class C cirrhosis

- History of a previous reaction to contrast media

- History of bronchial asthma

- History of allergic disorders

- Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the
perioperative liver transplantation period