Research Study for Children, Teens and Adults with Liver Disease Who Are Scheduled for a Clinical MRE
Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about whether ultrasound, which uses sound waves to make an image and measure how hard tissue is, can determine the presence and severity of liver disease.
Who can participate?
Those eligible for this study are children, teens and adults, up to age 25, who:
• Have liver disease
• Are undergoing a magnetic resonance elastography (MRE) exam of the liver as part of routine clinical care
• Can lie still for 10 to 15 minutes and follow breathing instructions
- Radiology - Imaging - X-Rays
- Gastroenterology - Digestive Tract - Stomach - Liver
What will happen in the study?
If you (as a participant who is 18 or older) or your child qualifies, and you decide you want to take part in the study, you will have 1 short visit, lasting about 30 minutes, immediately before or after your clinical MRE at Cincinnati Children’s.
During this study, we will review you or your child’s medical record to obtain information about your liver disease.
In addition to the normal work-up for you or your child’s liver disease, you will have 1 additional imaging study, an ultrasound with acoustic radiation force impulse (ARFI) imaging. This ultrasound will be performed by an ultrasound technologist and will take about 10 to 15 minutes.
While in the ultrasound, you or your child will need to hold relatively still and follow breathing instructions for 10 to 15 minutes while the images are obtained.
A radiologist (imaging doctor) will review all ultrasound images and report any abnormality to your child’s gastroenterologist. The images will NOT be part of the permanent clinical medical record.
After the imaging is done, you or your child will be called and asked a 1-question survey about which imaging exam you preferred – MRI or ultrasound.
Research staff will explain the details of this study to you or your child as well as make sure that all of your questions are answered and that you understand what will happen to you during this study.
What are the good things that can happen from this research?
Being in this study may not help you or your child right now. When we finish the study, we hope that we will know more about the use of ultrasound in evaluating children with liver disease. This may help other children or young adults with liver disease later on.
What are the bad things that can happen from this research?
There is currently no known risk of the ultrasound imaging study and the U.S. Food and Drug Administration (FDA) has cleared the ultrasound machine and software as safe.
Other possible risks and discomforts will be discussed with parents, legal representatives or guardians interested in learning more about this study.
Will you/your child be paid to be in this research study?
Participants will not receive payment for being in this study; however, the study doctor will tell you if they find out about new information from this or other studies that may affect you or your child’s health, safety or willingness to stay in this study.
Also, there is no cost to you to be in this research study. You will NOT be charged for the research ultrasound.