Liver Lesions in Contrast-Enhanced Magnetic Resonance Imaging (MRI)
Conditions
Liver Neoplasms
Conditions: official terms
Liver Neoplasms
Conditions: Keywords
Liver Neoplasms, Liver lesions, Benign liver lesions, Malignant liver lesions, Contrast-Enhanced Magnetic Resonance Imaging, MRI, Gadoxetate, Eovist, Gadopentetate Dimeglumine, Magnevist
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Intervention
Name: Gadoxetate Type: Drug
Name: Gadopentetate Dimeglumine Type: Drug
Overall Status
Recruiting
Summary
The goal of this clinical research study is to learn if using 2 different kinds of contrast agents (Eovist [gadoxetate] and Gadovist [gadobutrol]) given at the same time is better than using 1 contrast agent alone in learning which liver lesions may be cancerous.

Contrast agents are used by doctors in order to see MRI images more clearly.
Detailed Description
If you agree to take part in this study, you will have your routine follow-up MRI as scheduled. On that day, you will receive gadoxetate by vein over about 1 minute, which is routine.

Then, at the 20 minute mark during your MRI, you will receive gadobutrol by vein over about 1 minute, which is considered research. Your MRI scan will then be completed as is routine. Researchers will then compare the images.

Adding the injection of gadobutrol will add about 5 minutes to the routine MRI. The MRI scan will take 30-45 minutes total.

Information from your medical records will also be collected as part of this study.

Length of Study:

Your active study participation will be over when the MRI is complete.

This is an investigational study. The MRI scan in this study is performed using an FDA-approved and commercially available method. Adding gadobutrol as a second contrast agent to try to learn which liver lesions may be cancerous is investigational.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Patients of any gender older than 18 years of age with the most recent abdominal MR study obtained within 3 months.

2. Patients with normal renal function (GFR>/= 60)

3. Any disease type

Exclusion Criteria:

1. Pediatric patients (< 18 years old)

2. Pregnant women

3. Patients with impaired renal function (GFR< 60)

4. Patients with surgical implants and/or metallic foreign bodies non-compatible with the MR magnet

5. Patients with contraindications to the use of intravenous contrast such as allergic type reactions
Location
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
October 2014
Sponsors
M.D. Anderson Cancer Center
Source
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page