Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

Not Applicable

Active, not recruiting

• Conditions: Metastatic Malignant Neoplasm in the Liver; Primary Malignant Liver Neoplasm; Hepatocellular Carcinoma; Liver and Intrahepatic Bile Duct Disorder
• Interventions: Procedure: Contrast-enhanced Magnetic Resonance Imaging; Drug: Gadobutrol; Drug: Gadoxetate Disodium

• Registration Number: NCT02156739
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Study Start: 2014-10-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (contrast-enhanced MRI)	Gadoxetate Disodium	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.
Diagnostic (contrast-enhanced MRI)	Contrast-enhanced Magnetic Resonance Imaging	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.
Diagnostic (contrast-enhanced MRI)	Gadobutrol	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States