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

NCT ID: NCT02578602

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-06-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (gadoxetate disodium MRI)

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

Group Type: EXPERIMENTAL

Gadoxetate Disodium

Intervention Type: DRUG

Given IV

Magnetic Resonance Imaging

Intervention Type: DEVICE

Undergo MRI with gadoxetate disodium

Interventions

Gadoxetate Disodium

Given IV

Intervention Type: DRUG

Magnetic Resonance Imaging

Undergo MRI with gadoxetate disodium

Intervention Type: DEVICE

Other Intervention Names

Eovist; Gadolinium EOB DTPA; Gadolinium Ethoxybenzyl Diethylenetriaminepentaacetic Acid; Gadoxetic Acid Disodium; Gd-(S)-EOB-DTPA; Gd-EOB-DTPA; Primovist; ZK 139834; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MRI; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilbert Whang

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

NCI-2014-01850

Identifier Type: REGISTRY

Identifier Source: secondary_id

USC 3L-10-1

Identifier Type: -

Identifier Source: secondary_id

HS-10-00188

Identifier Type: -

Identifier Source: secondary_id

3L-10-1

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3L-10-1

Identifier Type: -

Identifier Source: org_study_id