Overview

Researchers at the Children’s Hospital Medical Center, Cincinnati are translating noncontrast, novel Magnetic Resonance Imaging (MRI) techniques for detecting and measuring intestinal inflammation. The clinical trial also attempts to predict a response to medical therapy in small bowel Crohn’s disease (CD). 

Study Information

The study will consist of two groups: a control group of healthy subjects and a group of newly diagnosed Crohn’s patients. MR imaging will be used as an intervention to uncover the differences in subjects of both groups. The sessions will last 30-45 minutes with the purpose of predicting the therapeutic response in Crohn’s patients.

Inclusion Criteria

Healthy Control Group

• Able to tolerate up to 45 minutes in an MRI scanner

Newly Diagnosed Crohn’s Group

• Newly diagnosed small bowel Crohn’s disease
• Expected to receive infliximab or other anti-Tumor Necrosis Factor (anti-TNF) medical therapy
• Between 11 to 25 years old and able to assent/consent
• Available for follow-up MRI at 4-weeks and 6-months after start of treatment,
• Able to tolerate up to 45 minutes in an MRI scanner.

Exclusion Criteria

Healthy Control Group

• Inability to obtain assent/consent,
• Inability to tolerate 45 minutes in an MRI scanner,
• Contraindication to MRI (e.g., MRI incompatible implant or support device),
• Previous (remote) diagnosis or treatment of inflammatory bowel disease or other intestinal disease,
• History of intra-abdominal surgery, including surgery on the intestine,
• Pregnancy. Point-of-care urine pregnancy testing will be performed on all female study participants of reproductive potential (pediatric and adult) prior to each research MRI exam.

Newly Diagnosed Crohn’s Group

• Inability to obtain assent/consent
• Inability to tolerate 45 minutes in an MRI scanner
• Contraindication to MRI (e.g., MRI incompatible implant or support device)
• Previous (remote) diagnosis or treatment of inflammatory bowel disease
• History of intra-abdominal surgery, including surgery on the intestine
• Known bleeding disorder/coagulopathy
• Pregnancy

Locations

You may participate in this study at Cincinnati Children’s Hospital Medical Center in Cincinnati, Ohio, United States, 45229. If you have any questions or concerns, feel free to contact Becky Imbus, BA at 513-636-9403 or at rebecca.imbus@cchmc.org. 

Sponsors/Collaborators

This clinical trial is sponsored by Children’s Hospital Medical Center, Cincinnati with Jonathan R Dillman, MD, MSc as the Principal Investigator.