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 the liver. We want to use a special kind of ultrasound to measure liver hardness or stiffness in children and young adults that have a healthy functioning liver.
We are asking you and others without liver disease to be in the research, because to better diagnose liver disease by ultrasound based on abnormal liver stiffness, we need to understand what normal liver stiffness is.
Who can participate?
Babies, children, teens, adults and seniors, of all ages, who:
- Are scheduled for an outpatient ultrasound in the Department of Radiology and Medical Imaging at Cincinnati Children’s
- Have no known or suspected history of liver disease
- Are not pregnant
What will happen in the study?
If you (as a participant who is 18 or older) or your child qualify and you decide to take part in the study, you will have 1 visit lasting about 20 to 30 minutes.
Research study staff will give you a document that explains the details of this study. They will go over this document with you and/or your child and make sure that all of your questions are answered. The study procedures will not begin until informed consent is obtained.
You or your child will need to stop eating and drinking 4 hours before the study visit.
At the study visit, you or your child will have the following tests and procedures:
- Height and weight measurements
- Verbal pregnancy test - if applicable
- Ultrasound exam - a machine that uses sound waves to take pictures of the liver
What are the good things that can happen from this research?
You or your child may not receive a direct medical benefit from participating in this study. However, when we finish the study, we hope to know more about normal liver stiffness as measured with Toshiba ultrasound. This may help other children with liver disease later on.
What are the bad things that can happen from this research?
There is no known risk from the ultrasound exam being performed. The hardware and software being used for this study are approved by the US Food and Drug Administration (FDA) and are used clinically here at Cincinnati Children’s as well as at other hospitals around the world.
There may be other risks that we do not know about yet.