Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02156739

Collaborator

National Cancer Institute (NCI) (NIH)

100

Enrollment

Location

Arm

127.6

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Liver and Intrahepatic Bile Duct Disorder Metastatic Malignant Neoplasm in the Liver Primary Malignant Liver Neoplasm	Procedure: Contrast-enhanced Magnetic Resonance Imaging Drug: Gadobutrol Drug: Gadoxetate Disodium	N/A

Detailed Description

PRIMARY OBJECTIVES:

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced MRI

Actual Study Start Date :

Oct 13, 2014

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Contrast-enhanced Magnetic Resonance Imaging Undergo contrast-enhanced MRI Other Names: CONTRAST ENHANCED MRI Contrast-enhanced MRI Drug: Gadobutrol Given IV Other Names: BAY86-4875 Gadavist Gadograf Gadovist Protovis ZK 135079 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

Arm

Intervention/Treatment

Experimental: 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.

Procedure: Contrast-enhanced Magnetic Resonance Imaging

Undergo contrast-enhanced MRI

Other Names:

CONTRAST ENHANCED MRI

Contrast-enhanced MRI

Drug: Gadobutrol

Given IV

Other Names:

BAY86-4875

Gadavist

Gadograf

Gadovist

Protovis

ZK 135079

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

Outcome Measures

Primary Outcome Measures

Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI) [Up to 4 years]
Summary statistics of sensitivity, specificity, true positives, true negatives, false positives, and false negatives will be provided for gadoxetate disodium and gadoxetate disodium + gadobutrol method. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value will be estimated along with corresponding 95% confidence intervals for the two methods. Comparison between the two methods will be made following method by Obuchowski. Other statistical analyses will be carried out as appropriate.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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