Needed: Children, Teens and Adults 8 to 21 Years Old with Liver Fibrosis Confirmed by a Biopsy

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to compare MR imaging (MRI) techniques to see and measure liver fibrosis.

The MRI sequences being compared include both Food and Drug Administration (FDA) approved and currently unapproved, or investigational, sequences. Both the approved and investigational sequences meet standard MR safety guidelines defined by the FDA.

Who can participate?

Children, teens and adults, 8 to 21 years old, who have liver fibrosis confirmed by a biopsy, may be eligible for participation. The liver biopsy must have occurred within 6 months prior to the research study MRI exam.

Conditions

  • Gastroenterology - Digestive Tract - Stomach - Liver

What will happen in the study?

If you (as a participant 18 or older) or your child are interested and eligible for participation, you will come to Cincinnati Children’s for 1 research study visit lasting about 2-and-a-half hours.

At the start of the study visit, you or your child will be weighed and measured. Study staff will also review you or your child’s medical chart for information related to liver health.

Then, study staff will ask you or your child to complete MRI images of the liver using 8 different MRI sequences, all of which will be performed on a research MRI scanner in the Imaging Research Center (IRC) at Cincinnati Children’s. This scanner is the same scanner as 2 clinical scanners used every day at Cincinnati Children’s.

You or your child will complete MRI images for around 90 minutes. The images will be de-identified (personal identifying information will be removed) for analysis for this research study and then retained in de-identified form for potential future studies. 

After the visit, study staff will compare the different MRI sequences for how well they see and measure fibrosis and how well they give the same result when repeated.

Participants, parents or guardians interested in learning more about this study will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. 

What are the good things that can happen from this research?

You or your child may not receive a direct medical benefit from being in this study right now. However, when we finish the study, we hope to know more about using MRI methods for seeing and measuring liver fibrosis. This may help patients in the future.

What are the bad things that can happen from this research?

There are no known risks from having an MRI or from use of the imaging sequences being investigated. However, some people are claustrophobic and may become anxious, fearful, or nervous in the MR scanner. Should you or your child become uncomfortable at any time, the scan will be stopped immediately.

There may be unknown or unforeseen risks associated with study participation.

A detailed list of possible risks will be provided to those participants, parents or guardians interested in knowing more about this study.

Will you/your child be paid to be in this research study?

Participants may receive $75 for their time, effort and travel.

Contact

Contact Us.Lauren Kirgis
lauren.kirgis@cchmc.org
513-636-3760
Cincinnati Children’s Hospital Medical Center
Division of Radiology and Medical Imaging
3333 Burnet Avenue
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Andrew Trout, MD
Cincinnati Children’s Hospital Medical Center
Chief, Nuclear Medicine, Department of Radiology and Medical Imaging
Radiologist, Department of Radiology and Medical Imaging

CCHMC IRB #2016-8503: V1