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Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02156739
Recruitment Status : Active, not recruiting
First Posted : June 5, 2014
Last Update Posted : October 19, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 : June 1, 2024
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Other Names:
  • CONTRAST ENHANCED MRI
  • Contrast-enhanced MRI

Drug: Gadobutrol
Given IV
Other Names:
  • BAY86-4875
  • Gadavist
  • Gadograf
  • Gadovist
  • Protovis
  • ZK 135079

Drug: Gadoxetate Disodium
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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Janio Szklaruk, MD, PHD M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02156739    
Other Study ID Numbers: 2012-1157
NCI-2014-02333 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2012-1157 ( Other Identifier: M D Anderson Cancer Center )
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: October 19, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Liver Neoplasms
Bile Duct Diseases
Liver Diseases
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Biliary Tract Diseases
Edetic Acid
Pentetic Acid
 Antidotes
Protective Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents
Anticoagulants
Calcium Chelating Agents