Early MRI Prediction of Crohns



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:11 - 25
Updated:2/3/2019
Start Date:December 17, 2018
End Date:December 2020
Contact:Becky Imbus, BA
Email:rebecca.imbus@cchmc.org
Phone:513-636-9403

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Early MRI Prediction of Response to Medical Therapy and Mucosal Healing in Small Bowel Crohn's Disease

The investigators plan a prospective study designed to optimize and translate noncontrast,
novel Magnetic Resonance Imaging (MRI) techniques for detecting and measuring intestinal
inflammation as well as for allowing early prediction of response to medical therapy in small
bowel Crohn's Disease (CD).

The investigators plan to evaluate novel MRI techniques to measure: 1) mesenteric/intestinal
blood flow using phase-contrast cine MRI, 2) intestinal motility (peristalsis) using dynamic
cine MRI, and 3) bowel wall perfusion and molecular water diffusion. Precise objective
measurements of diseased bowel blood flow (in ml/min) and bowel motility (in contractions per
minute) are not currently used in the clinical care of CD patients, while diffusion-weighted
imaging is typically used in a qualitative manner. None of these techniques have been
evaluated for predicting eventual response to therapy or correlated with endoscopic mucosal
healing in pediatric or adult CD.

Inclusion Criteria:

Healthy Control Group

-Be able to tolerate up to 45 minutes in an MRI scanner

Newly Diagnosed Crohns Group

- Newly diagnosed, pathology-confirmed diagnosis of small bowel Crohn's disease,

- Expected to receive infliximab (Remicade; Janssen Biotech, Inc.) or other anti-Tumor
Necrosis Factor (anti-TNF) medical therapy,

- Between 11 to 25 years of age and able to assent/consent,

- Be available for follow-up MRI at 4-weeks and 6-months after the initiation of
treatment,

- Be 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 Crohns 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 (contraindication for adult subjects, as this may
increase the risk of research colonoscopy),

- 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.
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-636-9403
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