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Trial record 3 of 44 for:    Gadoxetate

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

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ClinicalTrials.gov Identifier: NCT02578602
Recruitment Status : Completed
First Posted : October 19, 2015
Last Update Posted : October 19, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
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 Drug: Gadoxetate Disodium Device: Magnetic Resonance Imaging Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MR Techniques in the Evaluation of Hepatocellular Carcinoma: Gadoxetate
Study Start Date : October 2010
Actual Primary Completion Date : November 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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:
  • Eovist
  • Gadolinium EOB DTPA
  • Gadolinium Ethoxybenzyl Diethylenetriaminepentaacetic Acid
  • Gadoxetic Acid Disodium
  • Gd-(S)-EOB-DTPA
  • Gd-EOB-DTPA
  • Primovist
  • ZK 139834

Device: Magnetic Resonance Imaging
Undergo MRI with gadoxetate disodium
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578602


Locations
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United States, California
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Gilbert Whang University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02578602     History of Changes
Other Study ID Numbers: 3L-10-1
NCI-2014-01850 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
USC 3L-10-1
HS-10-00188
3L-10-1 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: October 19, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pentetic Acid
Antidotes
Protective Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents