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Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

NCT ID: NCT02156739

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-13

Study Completion Date

2026-06-01

Brief Summary

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This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.

Detailed Description

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PRIMARY OBJECTIVES:

I. To compare the specificity of contrast enhanced MRI using a liver specific agent Eovist (gadoxetate disodium) versus the combined use of Eovist and an intravascular-extracellular agent Gadavist (gadobutrol) for the radiologic detection and characterization of liver lesions via clinical stability and follow up imaging.

OUTLINE:

Patients receive gadoxetate disodium intravenously (IV) over 1 minute and undergo MRI. Patients then receive gadobutrol IV over 1 minute at the 20 minute mark during MRI.

Conditions

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Hepatocellular Carcinoma Liver and Intrahepatic Bile Duct Disorder Metastatic Malignant Neoplasm in the Liver Primary Malignant Liver Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (contrast-enhanced MRI)

Patient receives each of these over one minute. For the gadoxetate disodium, dynamic imaging is performed immediately and imaging is performed at 20 minutes. For the gadobutrol, dynamic imaging is performed immediately.

Group Type EXPERIMENTAL

Contrast-enhanced Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo contrast-enhanced MRI

Gadobutrol

Intervention Type DRUG

Given IV

Gadoxetate Disodium

Intervention Type DRUG

Given IV

Interventions

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Contrast-enhanced Magnetic Resonance Imaging

Undergo contrast-enhanced MRI

Intervention Type PROCEDURE

Gadobutrol

Given IV

Intervention Type DRUG

Gadoxetate Disodium

Given IV

Intervention Type DRUG

Other Intervention Names

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CONTRAST ENHANCED MRI Contrast-enhanced MRI BAY86-4875 Gadavist Gadograf Gadovist Protovis ZK 135079 Eovist Gadolinium EOB DTPA Gadolinium Ethoxybenzyl Diethylenetriaminepentaacetic Acid Gadoxetic Acid Disodium Gd-(S)-EOB-DTPA Gd-EOB-DTPA Primovist ZK 139834

Eligibility Criteria

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Inclusion Criteria

* Patients with the most recent abdominal magnetic resonance (MR) study obtained within 3 months +/- 1 week
* Patients with renal function (estimated glomerular filtration rate \[eGFR\] \>= 30)
* Any disease type

Exclusion Criteria

* Pregnant women
* Patients with impaired renal function (eGFR \< 30)
* Patients with surgical implants and/or metallic foreign bodies non-compatible with the MR magnet
* Patients with contraindications to the use of intravenous contrast such as allergic type reactions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janio Szklaruk, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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NCI-2014-02333

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-1157

Identifier Type: OTHER

Identifier Source: secondary_id

2012-1157

Identifier Type: -

Identifier Source: org_study_id