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

Primary Purpose

Adult Hepatocellular Carcinoma, Advanced Adult Hepatocellular Carcinoma, BCLC Stage 0 Adult Hepatocellular Carcinoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gadoxetate Disodium
Magnetic Resonance Imaging
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adult Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (gadoxetate disodium MRI)

Arm Description

Patients receive gadoxetate disodium IV and then undergo enhanced liver MRI.

Outcomes

Primary Outcome Measures

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
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

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

Full Information

First Posted
September 13, 2015
Last Updated
October 14, 2015
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02578602
Brief Title
MRI With Gadoxetate Disodium in Measuring Tumors in Patients With Liver Cancer
Official Title
MR Techniques in the Evaluation of Hepatocellular Carcinoma: Gadoxetate
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Hepatocellular Carcinoma, Advanced Adult Hepatocellular Carcinoma, BCLC Stage 0 Adult Hepatocellular Carcinoma, BCLC Stage A Adult Hepatocellular Carcinoma, BCLC Stage B Adult Hepatocellular Carcinoma, BCLC Stage C Adult Hepatocellular Carcinoma, BCLC Stage D Adult Hepatocellular Carcinoma, Localized Non-Resectable Adult Liver Carcinoma, Localized Resectable Adult Liver Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (gadoxetate disodium MRI)
Arm Type
Experimental
Arm Description
Patients receive gadoxetate disodium IV and then undergo enhanced liver MRI.
Intervention Type
Drug
Intervention Name(s)
Gadoxetate Disodium
Other Intervention Name(s)
Eovist, Gadolinium EOB DTPA, Gadolinium Ethoxybenzyl Diethylenetriaminepentaacetic Acid, Gadoxetic Acid Disodium, Gd-(S)-EOB-DTPA, Gd-EOB-DTPA, Primovist, ZK 139834
Intervention Description
Given IV
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI with gadoxetate disodium
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
Changes in apparent diffusion coefficient (ADC) values within lesions and within normal liver before and after administration of Gadoxetate
Description
ADC values will be recorded for uninvolved liver parenchyma and for tumors before and after administration of gadoxetate disodium.
Time Frame
Up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilbert Whang
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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

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