Clinical trial NCT03340519: Early MRI Prediction of Crohns
Official title: Early MRI Prediction of Response to Medical Therapy and Mucosal Healing in Small Bowel Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Keywords: Crohn
MRI
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 35
Sex: ALL
Minimum age (years): 11
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Control Group General population Newly Diagnosed Crohns Group Cincinnati Children's Inflammatory Bowel Disease Clinic

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prediction of therapeutic response in patients with Crohns disease
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jonathan R Dillman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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