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

Advanced Adult Hepatocellular Carcinoma Clinical Trial

Official title:

MR Techniques in the Evaluation of Hepatocellular Carcinoma: Gadoxetate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578602
• Other study ID #: 3L-10-1
• Secondary ID: NCI-2014-01850US
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2015
• Last updated: October 14, 2015
• Start date: October 2010
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• 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
• Carcinoma
• Carcinoma, Hepatocellular
• Localized Non-Resectable Adult Liver Carcinoma
• Localized Resectable Adult Liver Carcinoma

Intervention

Drug:
• Gadoxetate Disodium
Given IV

Device:
• Magnetic Resonance Imaging
Undergo MRI with gadoxetate disodium

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 24 hours	No
Secondary	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.	Up to 24 hours	No