Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT02946203
Brief Summary:
In this research study, two different oral contrast materials that can be used for CT or MR enterography will be studied. This study is designed to compare which oral contrast material (VoLumen or Breeza) is preferred by pediatric patients and which provides higher quality exams.
Detailed Description:
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.
Study:
NCT02946203
Study Brief:
Protocol Section:
NCT02946203