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Active, Not Recruiting

NCT Number: NCT02156739

Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Liver and Intrahepatic Bile Duct Disorder Metastatic Malignant Neoplasm in the Liver Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Primary Malignant Liver Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contrast-enhanced Magnetic Resonance Imaging

Procedure

Undergo contrast-enhanced MRI

Other names: CONTRAST ENHANCED MRI, Contrast-enhanced MRI

Gadobutrol

Drug

Given IV

Other names: BAY86-4875, Gadavist, Gadograf, Gadovist, Protovis, ZK 135079

Gadoxetate Disodium

Drug

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

Primary outcomes

  1. Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Jun 5, 2014
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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