Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason

• Register: ClinicalTrials.gov
• Last refreshed on: 9 October 2023
• Main ID: NCT03492944
• Date of registration: 12/02/2018
• Prospective Registration: Yes
• Primary sponsor: Children's Hospital Medical Center, Cincinnati
• Public title: Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason
• Scientific title: Contrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI Enterography
• Date of first enrolment: March 6, 2020
• Target sample size: 25
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03492944
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Becky Imbus, BA

• Name: Jonathan Dillman, MD,MSc
• Affiliation: Children's Hospital Medical Center, Cincinnati

Key inclusion & exclusion 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.



Age minimum: 10 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Device: Ultrasound Imaging

Drug: Ultrasound Microbubble Contrast Agent

Primary Outcome(s)

Degree of bowel wall enhancement [Time Frame: 2 years]

Secondary Outcome(s)

Degree of mesenteric inflammation [Time Frame: 2 years]

Maximum Bowel Wall Thickness [Time Frame: 2 years]

Overall Disease Status for imaged section [Time Frame: 2 years]

Secondary ID(s)

CIN_Lumason Crohns_001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors