NCT03492944Completed
Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason
Contrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI Enterography
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 25 (actual)
- First submitted
- 12 Feb 2018
- Start date
- 6 Mar 2020
- Primary completion date
- 12 Jun 2024
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Crohn's disease
- NCT number
- NCT03492944
What you commit to
- Study type: Observational
- Participants enrolled: 25
- From 6 Mar 2020 to the primary completion date, 12 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allergic-like reaction or other severe adverse event to Lumason or any of the active ingredients in Lumason (SPECIFIC CONTRAINDICATION from Package Insert).
Other illness
- Obesity/body habitus preventing visualization of small bowel affected by Crohn's disease by ultrasound (Body mass index ≥30 kg/m2
Lab values
- 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.
Age
- Patients under the age of 10 or over the age of 18.
Other
- Pregnancy or breast feeding. Urine pregnancy testing will be performed on all female study participants of reproductive potential.
- Subject inability/unwillingness to consent or child assent, including severe developmental delay/mental retardation.
Who the study is looking for
- 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
Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.