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OpenTrials
Completed

NCT Number: NCT03492944

Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason

The investigators plan to compare contrast-enhanced ultrasound to CT and MRI for the detection and quantification of intestinal inflammation in the the setting of pediatric small bowel Crohns disease

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

The proposed study will investigate the use of an FDA-approved ultrasound microbubble contrast agent (Lumason; Bracco Diagnostics) in pediatric and adult Crohn's disease patients undergoing either MR enterography (MRE, or MRI of the bowel) or CT enterography (CTE, or CT of the bowel). In April 2016, Lumason was FDA approved for intravenous administration and imaging of the liver in children. Imaging of the bowel will employ an identical administration method to that described for liver imaging, but the ultrasound transducer will be placed over the affected intestines as opposed to liver.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • histologic evidence of small bowel Crohn's disease, or clinical evidence of disease (including radiologic confirmation [either CT or MRI] and receiving medical therapy for Crohn's disease).
  • Between ages 10 and 18 years.
  • Undergoing clinically-indicated CTE or MRE with evidence of active disease based on pediatric gastroenterologist clinical assessment

Exclusion criteria

  • Patients under the age of 10 or over the age of 18.
  • Pregnancy or breast feeding. Urine pregnancy testing will be performed on all female study participants of reproductive potential.
  • Obesity/body habitus preventing visualization of small bowel affected by Crohn's disease by ultrasound (Body mass index ≥30 kg/m2
  • Subject inability/unwillingness to consent or child assent, including severe developmental delay/mental retardation.
  • Prior allergic-like reaction or other severe adverse event to Lumason or any of the active ingredients in Lumason (SPECIFIC CONTRAINDICATION from Package Insert).
  • Known unstable cardiopulmonary conditions (including any history of acute myocardial infarction/acute coronary artery syndrome, arrhythmia, and congestive heart failure), ongoing acute or chronic kidney disease (eGFR <30 ml/min), moderate/severe chronic lung disease, and end-stage liver disease.

Treatment and study plan

Ultrasound Microbubble Contrast Agent

Drug

Patients undergoing a clinically ordered CT or MRI Enterography for Crohn disease will be recruited to undergo a contrast enhanced ultrasound study of the bowel

Other names: Lumason

Ultrasound Imaging

Device

Patients undergoing a clinically ordered CT or MRI Enterography for Crohn disease will be recruited to undergo a contrast enhanced ultrasound study of the bowel

Primary outcomes

  1. Degree of bowel wall enhancement

    Time frame: 2 years

    Percent hyperenhancement (compared to normal bowel loops)

Secondary outcomes

  1. Overall Disease Status for imaged section

    Time frame: 2 years

    status of inactive, mild activity, moderate activity and severe activity

  2. Degree of mesenteric inflammation

    Time frame: 2 years

    Inflammation assessed as none, mild, moderate, severe

  3. Maximum Bowel Wall Thickness

    Time frame: 2 years

    Measured

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Contrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI Enterography

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Apr 10, 2018
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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