Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02156739
• Other study ID #: 2012-1157
• Secondary ID: NCI-2014-0233320
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 13, 2014
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Contrast-enhanced Magnetic Resonance Imaging
Undergo contrast-enhanced MRI

Drug:
• Gadobutrol
Given IV
• Gadoxetate Disodium
Given IV

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI)	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.	Up to 4 years

External Links

•   University of Texas MD Anderson Cancer Center Website