Early MRI Prediction of Crohns

Completed

• Conditions: Crohn Disease

• Registration Number: NCT03340519
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-13
• Study Start: 2018-12-17
• Primary Completion: 2021-10-25
• Study Completion: 2024-12-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prediction of therapeutic response in patients with Crohns disease	30 minutes	Assess novel MRI techniques for ability to predict early response to infliximab therapy in 20 newly diagnosed small bowel CD patients.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States