Comparison of VoLumen and Breeza Oral Contrast Agents in Pediatric Patients

NCT02946203 | Completed Phase 4

• 1 other identifier: CIN_Breeza_001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (4)

• Degree of bowel opacification as determined by estimated percentage of overall small bowel opacification

  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.

  1 year

• Degree of bowel opacification, rated subjectively as excellent, diagnostic, suboptimal or poor

  To compare the degree of bowel opacification provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography.

  1 year

• Degree of bowel distention as determined by measurement of the largest diameter, normal, small bowel loop in each of the four abdominal quadrants

  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

  1 year

• Degree of bowel distention rated subjectively as excellent, diagnostic, suboptimal or poor

  To compare the degree of bowel distention provided by Breeza vs. VoLumen oral contrast materials in pediatric patients undergoing CT and MR enterography

  1 year

Secondary Outcomes (2)

• Tolerability as assessed by patient survey with respect to overall tolerability, taste and texture

  1 year

• Tolerability as assessed by patient survey with respect to abdominal symptoms as well as overall state of well-being

  1 year

Study Arms (2)

Flavored Beverage Oral Contrast-Breeza

ACTIVE COMPARATOR

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.

Other: Flavored beverage Oral Contrast

Barium Sulfate Oral Contrast-VoLumen

ACTIVE COMPARATOR

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.

Other: Barium Sulfate

Interventions

Barium Sulfate OTHER

Barium Sulfate Oral Contrast-VoLumen

Also known as: VoLumen

Barium Sulfate Oral Contrast-VoLumen

Flavored beverage Oral Contrast OTHER

Flavored beverage for neutral abdominal/pelvic imaging

Also known as: Breeza

Flavored Beverage Oral Contrast-Breeza

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age \> 8 years and \< 18 years
• Patients undergoing clinically indicated CT or MR enterography

You may not qualify if:

• Age \< 8 years and ≥ 18 years
• Requirement for sedation for CT or MRI enterography
• Cannot drink oral contrast (will require tube administration)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (6)

• 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.

  PMID: 19936733 BACKGROUND

• 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.

  PMID: 25531478 BACKGROUND

• 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.

  PMID: 24224581 BACKGROUND

• 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.

  PMID: 18303285 BACKGROUND

• 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.

  PMID: 22915428 BACKGROUND

• 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.

  PMID: 26998661 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Barium Sulfate

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Barium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Jonathan Dillman, MD, MSc

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 27, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)