Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason (NCT03492944) | Clinical Trial Compass
CompletedNot Applicable
Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason
United States25 participantsStarted 2020-03-06
Plain-language 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
Who can participate
Age range
10 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Degree of bowel wall enhancement
Timeframe: 2 years
Trial details
NCT IDNCT03492944
SponsorChildren's Hospital Medical Center, Cincinnati