Hepatocellular Carcinoma, Liver and Intrahepatic Bile Duct Disorder, Metastatic Malignant Neoplasm in the Liver, Primary Malignant Liver Neoplasm
Conditions
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.
Interventions
Undergo contrast-enhanced MRI
DRUGGadobutrol
Given IV
Given IV
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed