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

Phase 1

Completed

• Conditions: Localized Resectable Adult Liver Carcinoma; Adult Hepatocellular Carcinoma; BCLC Stage B Adult Hepatocellular Carcinoma; BCLC Stage 0 Adult Hepatocellular Carcinoma; BCLC Stage C Adult Hepatocellular Carcinoma; BCLC Stage D Adult Hepatocellular Carcinoma; Advanced Adult Hepatocellular Carcinoma; BCLC Stage A Adult Hepatocellular Carcinoma; Localized Non-Resectable Adult Liver Carcinoma
• Interventions: Drug: Gadoxetate Disodium; Device: Magnetic Resonance Imaging

• Registration Number: NCT02578602
• Lead Sponsor: University of Southern California

Brief 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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2014-11
• Study Completion: 2015-06
• Study First Submitted: 2015-09-13
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-14
• Last Update Submitted: 2015-10-14
• Study First Posted: 2015-10-19
• Last Update Posted: 2015-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (gadoxetate disodium MRI)	Magnetic Resonance Imaging	Patients receive gadoxetate disodium IV and then undergo enhanced liver MRI.
Diagnostic (gadoxetate disodium MRI)	Gadoxetate Disodium	Patients receive gadoxetate disodium IV and then undergo enhanced liver MRI.

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States