Crohn Disease
Conditions
Brief summary
The investigators plan to compare contrast-enhanced ultrasound to CT and MRI for the detection and quantification of intestinal inflammation in the the setting of pediatric small bowel Crohns disease
Detailed description
The proposed study will investigate the use of an FDA-approved ultrasound microbubble contrast agent (Lumason; Bracco Diagnostics) in pediatric and adult Crohn's disease patients undergoing either MR enterography (MRE, or MRI of the bowel) or CT enterography (CTE, or CT of the bowel). In April 2016, Lumason was FDA approved for intravenous administration and imaging of the liver in children. Imaging of the bowel will employ an identical administration method to that described for liver imaging, but the ultrasound transducer will be placed over the affected intestines as opposed to liver.
Interventions
DRUGUltrasound Microbubble Contrast Agent
Patients undergoing a clinically ordered CT or MRI Enterography for Crohn disease will be recruited to undergo a contrast enhanced ultrasound study of the bowel
DEVICEUltrasound Imaging
Patients undergoing a clinically ordered CT or MRI Enterography for Crohn disease will be recruited to undergo a contrast enhanced ultrasound study of the bowel
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* histologic evidence of small bowel Crohn's disease, or clinical evidence of disease (including radiologic confirmation \[either CT or MRI\] and receiving medical therapy for Crohn's disease). * Between ages 10 and 18 years. * Undergoing clinically-indicated CTE or MRE with evidence of active disease based on pediatric gastroenterologist clinical assessment
Exclusion criteria
* Patients under the age of 10 or over the age of 18. * Pregnancy or breast feeding. Urine pregnancy testing will be performed on all female study participants of reproductive potential. * Obesity/body habitus preventing visualization of small bowel affected by Crohn's disease by ultrasound (Body mass index ≥30 kg/m2 * Subject inability/unwillingness to consent or child assent, including severe developmental delay/mental retardation. * Prior allergic-like reaction or other severe adverse event to Lumason or any of the active ingredients in Lumason (SPECIFIC CONTRAINDICATION from Package Insert). * Known unstable cardiopulmonary conditions (including any history of acute myocardial infarction/acute coronary artery syndrome, arrhythmia, and congestive heart failure), ongoing acute or chronic kidney disease (eGFR \<30 ml/min), moderate/severe chronic lung disease, and end-stage liver disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of bowel wall enhancement | 2 years | Percent hyperenhancement (compared to normal bowel loops) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Disease Status for imaged section | 2 years | status of inactive, mild activity, moderate activity and severe activity |
| Degree of mesenteric inflammation | 2 years | Inflammation assessed as none, mild, moderate, severe |
| Maximum Bowel Wall Thickness | 2 years | Measured |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathan Dillman, MD,MSc
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed