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

October 14, 2015 updated by: University of Southern California

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (gadoxetate disodium MRI)
Patients receive gadoxetate disodium IV and then undergo enhanced liver MRI.
Drug: Gadoxetate Disodium
Given IV
Other Names:
  • Primovist
  • Eovist
  • Gadolinium EOB DTPA
  • Gadolinium Ethoxybenzyl Diethylenetriaminepentaacetic Acid
  • Gadoxetic Acid Disodium
  • Gd-(S)-EOB-DTPA
  • Gd-EOB-DTPA
  • ZK 139834
Device: Magnetic Resonance Imaging
Undergo MRI with gadoxetate disodium
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Up to 24 hours
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.
Up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in apparent diffusion coefficient (ADC) values within lesions and within normal liver before and after administration of Gadoxetate
Time Frame: Up to 24 hours
ADC values will be recorded for uninvolved liver parenchyma and for tumors before and after administration of gadoxetate disodium.
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Gilbert Whang, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 13, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimate)

October 19, 2015

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3L-10-1 (Other Identifier: USC / Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH Grant/Contract)
  • NCI-2014-01850 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • USC 3L-10-1
  • HS-10-00188

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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