Comparison of VoLumen and Breeza Oral Contrast Agents in Pediatric Patients
Prospective Comparison of VoLumen and Breeza Oral Contrast Agents in Pediatric Patients Undergoing CT and MR Enterography
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Flavored Beverage Oral Contrast-Breeza
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.
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Flavored beverage for neutral abdominal/pelvic imaging
Other Names:
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Active Comparator: Barium Sulfate Oral Contrast-VoLumen
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.
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Barium Sulfate Oral Contrast-VoLumen
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Degree of bowel opacification as determined by estimated percentage of overall small bowel opacification
Time Frame: 1 year
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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.
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1 year
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Degree of bowel opacification, rated subjectively as excellent, diagnostic, suboptimal or poor
Time Frame: 1 year
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To compare the degree of bowel opacification provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography.
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1 year
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Degree of bowel distention as determined by measurement of the largest diameter, normal, small bowel loop in each of the four abdominal quadrants
Time Frame: 1 year
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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
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1 year
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Degree of bowel distention rated subjectively as excellent, diagnostic, suboptimal or poor
Time Frame: 1 year
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To compare the degree of bowel distention provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tolerability as assessed by patient survey with respect to overall tolerability, taste and texture
Time Frame: 1 year
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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
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1 year
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Tolerability as assessed by patient survey with respect to abdominal symptoms as well as overall state of well-being
Time Frame: 1 year
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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
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1 year
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Collaborators and Investigators
Publications and helpful links
General Publications
- Dillman JR, Adler J, Zimmermann EM, Strouse PJ. CT enterography of pediatric Crohn disease. Pediatr Radiol. 2010 Jan;40(1):97-105. doi: 10.1007/s00247-009-1465-5. Epub 2009 Nov 20.
- Mollard BJ, Smith EA, Dillman JR. Pediatric MR enterography: technique and approach to interpretation-how we do it. Radiology. 2015 Jan;274(1):29-43. doi: 10.1148/radiol.14122449.
- Towbin AJ, Sullivan J, Denson LA, Wallihan DB, Podberesky DJ. CT and MR enterography in children and adolescents with inflammatory bowel disease. Radiographics. 2013 Nov-Dec;33(7):1843-60. doi: 10.1148/rg.337105140.
- Young BM, Fletcher JG, Booya F, Paulsen S, Fidler J, Johnson CD, Huprich J, Barlow J, Trout A. Head-to-head comparison of oral contrast agents for cross-sectional enterography: small bowel distention, timing, and side effects. J Comput Assist Tomogr. 2008 Jan-Feb;32(1):32-8. doi: 10.1097/RCT.0b013e318061961d.
- Absah I, Bruining DH, Matsumoto JM, Weisbrod AJ, Fletcher JG, Fidler JL, Faubion WA Jr. MR enterography in pediatric inflammatory bowel disease: retrospective assessment of patient tolerance, image quality, and initial performance estimates. AJR Am J Roentgenol. 2012 Sep;199(3):W367-75. doi: 10.2214/AJR.11.8363.
- Kolbe AB, Fletcher JG, Froemming AT, Sheedy SP, Koo CW, Pundi K, Bruining DH, Tung J, Harmsen WS, Barlow JM, Fidler JL. Evaluation of Patient Tolerance and Small-Bowel Distention With a New Small-Bowel Distending Agent for Enterography. AJR Am J Roentgenol. 2016 May;206(5):994-1002. doi: 10.2214/AJR.15.15260. Epub 2016 Mar 21.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIN_Breeza_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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