Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason

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.

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.