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Completed

NCT Number: NCT03340519

Early MRI Prediction of Crohns

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).

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Key information

Age range

11 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MR Imaging

Device

Novel MR imaging will be performed to provide bowel anatomic and functional data

Primary outcomes

  1. Prediction of therapeutic response in patients with Crohns disease

    Time frame: 30 minutes

    Assess novel MRI techniques for ability to predict early response to infliximab therapy in 20 newly diagnosed small bowel CD patients.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2024
First posted
Nov 13, 2017
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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