Early MRI Prediction of Crohns

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Crohn Disease

Treatments: Device: MR Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT03340519

CIN_EarlyMRCrohns

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 35 patients

Sex: All

Ages: 11 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

35 participants in 2 patient groups

Healthy Controls

Description:

Healthy Controls will undergo MR imaging to optimize MR techniques for bowel assessment and to acquire normative data

Treatment:

Device: MR Imaging

Newly Diagnosed Crohns Patients

Description:

MR imaging will be performed in newly diagnosed CD patients prior to initiation of infliximab therapy in order to obtain baseline measures in the setting of active intestinal inflammation

Treatment:

Device: MR Imaging