Status:
COMPLETED
Early MRI Prediction of Crohns
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Crohn Disease
Eligibility:
All Genders
11-25 years
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 17 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 18 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03340519
Start Date
December 17 2018
End Date
December 18 2024
Last Update
February 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229