Early MRI Prediction of Crohns

NCT03340519 | Completed FDA Device

• 1 other identifier: CIN_EarlyMRCrohns
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Crohn Disease

Keywords

Crohn; MRI

Outcome Measures

Primary Outcomes (1)

• Prediction of therapeutic response in patients with Crohns disease

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

  30 minutes

Study Arms (2)

Healthy Controls

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

Device: MR Imaging

Newly Diagnosed Crohns Patients

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

Device: MR Imaging

Interventions

MR Imaging DEVICE

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

Healthy Controls; Newly Diagnosed Crohns Patients

Eligibility Criteria

• Age: 11 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Control Group General population Newly Diagnosed Crohns Group Cincinnati Children's Inflammatory Bowel Disease Clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (33)

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MeSH Terms

Conditions

Crohn Disease

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jonathan R Dillman, MD, MSc

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 13, 2017
• Study Start: December 17, 2018
• Primary Completion: October 25, 2021
• Study Completion: December 18, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)