Liver Lesions in Contrast-Enhanced Magnetic Resonance Imaging (MRI)
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2018 |
| Start Date: | October 2014 |
| End Date: | October 2020 |
| Contact: | Vikas Kundra, MD, PHD |
| Phone: | 713-745-2702 |
Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced Magnetic Resonance Imaging (MRI)
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.
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.
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.
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.
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.
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.
Inclusion Criteria:
1. Patients of any gender older than 18 years of age with the most recent abdominal MR
study obtained within 3 months +/- 1 week.
2. Patients with renal function (eGFR>/= 30)
3. Any disease type
Exclusion Criteria:
1. Pediatric patients (< 18 years old)
2. Pregnant women
3. Patients with impaired renal function (eGFR< 30)
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
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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