Comparison of VoLumen and Breeza Oral Contrast Agents in Pediatric Patients

Phase 4

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: Barium Sulfate; Other: Flavored beverage Oral Contrast

• Registration Number: NCT02946203
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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 Timeline

• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Study Start: 2016-11
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Barium Sulfate Oral Contrast-VoLumen	Barium Sulfate	Pediatric patients that are undergoing awake CT and MR enterography at the CCHMC base (Burnett) campus will be randomized to either VoLumen (current standard of care oral contrast) or Breeza.
Flavored Beverage Oral Contrast-Breeza	Flavored beverage Oral Contrast	Pediatric patients that are undergoing awake CT and MR enterography at the Cincinnati Children's Hospital Medical Center (CCHMC) base (Burnett) campus will be randomized to either VoLumen (current standard of care oral contrast) or Breeza.

Primary Outcome Measures

Name	Time	Method
Degree of bowel opacification as determined by estimated percentage of overall small bowel opacification	1 year	To compare the degree of bowel opacification provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography. The degree of bowel opacification will be rated 0-100 percent.
Degree of bowel distention as determined by measurement of the largest diameter, normal, small bowel loop in each of the four abdominal quadrants	1 year	To compare the degree of bowel distention, measured in millimeters, provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography
Degree of bowel distention rated subjectively as excellent, diagnostic, suboptimal or poor	1 year	To compare the degree of bowel distention provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography
Degree of bowel opacification, rated subjectively as excellent, diagnostic, suboptimal or poor	1 year	To compare the degree of bowel opacification provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography.

Secondary Outcome Measures

Name	Time	Method
Tolerability as assessed by patient survey with respect to abdominal symptoms as well as overall state of well-being	1 year	To compare the patient tolerability of Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography as assesses by patient survey using the Likert scale rating of 0-10
Tolerability as assessed by patient survey with respect to overall tolerability, taste and texture	1 year	To compare the patient tolerability of Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography as assessed by patient survey using the Likert scale rating of 0-10

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States