Comparison of VoLumen and Breeza Oral Contrast Agents in Pediatric Patients

VoLumen, a low Hounsfield unit 0.1% barium sulfate suspension that also contains sorbitol and
a gum, is the most common oral contrast material used in children and adults undergoing CT
and MR enterography (advanced imaging tests used to evaluate the bowel lumen and bowel wall
in children and adults, usually with suspected or known Crohn disease). This contrast
material is typically administered orally to non-sedated patients during the 45-60 minute
period prior to imaging. The goal of oral contrast material administration is to completely
fill the small bowel with fluid at the time of imaging. Benefits of oral contrast material at
cross-sectional enterography include: improved delineation of bowel from non-bowel structures
in the abdomen and pelvis, improved accuracy when assessing bowel wall thickness, and
improved visualization of mucosal hyper-enhancement in the setting of active intestinal
inflammation.

In some children (and adults), the standard-of-care contrast agent (VoLumen) is poorly
tolerated. This is likely due to a variety of factors, including taste, texture, and the
volume that is required to be consumed. Recently, a new oral contrast material called "Breeza
for neutral abdominopelvic imaging" (or simply Breeza) has become available for use at CT and
MR enterography. This agent contains sorbitol, mannitol, and xantham gum (a thickening
agent), and it is marketed as a "flavored beverage" as it contains no active ingredient
(e.g., barium sulfate). A single study performed in adult volunteers has shown that this new
agent performs similar to VoLumen, has a superior taste, and is associated with greater
willingness for repeat drinking.

The objective of our study is to compare our standard-of-care oral contrast material to the
newly available contrast material in a prospective, randomized, blinded manner. Primary
outcomes will include degree of small bowel opacification, distention of the terminal ileum,
and patient acceptance/tolerability.

Inclusion Criteria:

- Age > 8 years and < 18 years

- Patients undergoing clinically indicated CT or MR enterography

Exclusion Criteria:

- Age < 8 years and ≥ 18 years

- Requirement for sedation for CT or MRI enterography

- Cannot drink oral contrast (will require tube administration)