Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason
Completed
Conditions studied: Crohn Disease
In brief
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
Key facts
- Study ID
- NCT03492944
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 25
- Starts
- 2020-03-06
- Expected to finish
- 2025-10-30
- Last updated by the study team
- 2026-06-15
Who can join
Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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