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

Last updated: October 14, 2015
Sponsor: University of Southern California
Overall Status: Completed

Phase

1

Condition

Liver Cancer

Digestive System Neoplasms

Carcinoma

Treatment

N/A

Clinical Study ID

NCT02578602
3L-10-1
HS-10-00188
3L-10-1
USC 3L-10-1
NCI-2014-01850
P30CA014089
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • CT features suggestive of HCC, including those features which have been describedherein; 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 thefollowing 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 vascularstructures will be included, including the main portal vein, the main right andmain 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

Exclusion Criteria:

  • Unable to provide written and verbal informed consent

  • Unable to undergo MRI due to intraocular metallic foreign body, pacemaker, or othercontraindications including objects in the body which are deemed to be unsafe ornotable 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 ofless 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 theperioperative liver transplantation period

Study Design

Total Participants: 26
Study Start date:
October 01, 2010
Estimated Completion Date:
June 30, 2015

Study Description

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.

Connect with a study center

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

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