Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions
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|ClinicalTrials.gov Identifier: NCT02156739|
Recruitment Status : Recruiting
First Posted : June 5, 2014
Last Update Posted : October 3, 2019
|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||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced MRI|
|Actual Study Start Date :||October 13, 2014|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
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
Drug: Gadoxetate Disodium
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156739
|Contact: Vikas Kundra, MD, PHDfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Vikas Kundra 713-745-2702 email@example.com|
|Principal Investigator: Vikas Kundra|
|Principal Investigator:||Vikas Kundra||M.D. Anderson Cancer Center|