Clinical trial NCT03492944: Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason
Official title: Contrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI Enterography
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 25
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We plan to recruit approximately 25 subjects, 10-18 years of age, with known small bowel Crohn disease undergoing clinically indicated Computed Tomography Enterography (CTE) or Magnetic Resonance Enterography (MRE)imaging

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Degree of bowel wall enhancement
timeFrame: 2 years
Secondary outcomes:
measure: Overall Disease Status for imaged section
timeFrame: 2 years
measure: Degree of mesenteric inflammation
timeFrame: 2 years
measure: Maximum Bowel Wall Thickness
timeFrame: 2 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jonathan Dillman, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
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