Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason

Cincinnati Children's Hospital Medical Center

Status: Active, not recruiting

Conditions: Crohn Disease

Treatments: Device: Ultrasound Imaging; Drug: Ultrasound Microbubble Contrast Agent

Study type: Observational

Funder types: Other

Identifiers

NCT03492944

CIN_Lumason Crohns_001

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

25 participants in 1 patient group

Ultrasound Microbubble Contrast Agent

Description:

All subjects will receive intravenous Lumason microbubble contrast agent; there is no comparative ultrasound contrast agent. Contrast Enhanced Ultrasound findings/results will be correlated with comparable, clinically performed, CTE/MRE findings/results

Treatment:

Drug: Ultrasound Microbubble Contrast Agent

Device: Ultrasound Imaging