Early MRI Prediction of Crohns

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03340519
• Other study ID #: CIN_EarlyMRCrohns
• Status: Active, not recruiting
• Start date: December 17, 2018
• Est. completion date: September 25, 2024

Study information

• Verified date: February 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: September 25, 2024
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Device:
• MR Imaging
Novel MR imaging will be performed to provide bowel anatomic and functional data

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (33)

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Walters TD, Kim MO, Denson LA, Griffiths AM, Dubinsky M, Markowitz J, Baldassano R, Crandall W, Rosh J, Pfefferkorn M, Otley A, Heyman MB, LeLeiko N, Baker S, Guthery SL, Evans J, Ziring D, Kellermayer R, Stephens M, Mack D, Oliva-Hemker M, Patel AS, Kirschner B, Moulton D, Cohen S, Kim S, Liu C, Essers J, Kugathasan S, Hyams JS; PRO-KIIDS Research Group. Increased effectiveness of early therapy with anti-tumor necrosis factor-alpha vs an immunomodulator in children with Crohn's disease. Gastroenterology. 2014 Feb;146(2):383-91. doi: 10.1053/j.gastro.2013.10.027. Epub 2013 Oct 23. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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