Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason

June 11, 2025 updated by: Children's Hospital Medical Center, Cincinnati

Contrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI Enterography

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

We plan to recruit approximately 25 subjects, 10-18 years of age, with known small bowel Crohn disease undergoing clinically indicated Computed Tomography Enterography (CTE) or Magnetic Resonance Enterography (MRE)imaging

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ultrasound Microbubble Contrast Agent
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
Drug: Ultrasound Microbubble Contrast Agent
Patients undergoing a clinically ordered CT or MRI Enterography for Crohn disease will be recruited to undergo a contrast enhanced ultrasound study of the bowel
Other Names:
  • Lumason
Device: Ultrasound Imaging
Patients undergoing a clinically ordered CT or MRI Enterography for Crohn disease will be recruited to undergo a contrast enhanced ultrasound study of the bowel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of bowel wall enhancement
Time Frame: 2 years
Percent hyperenhancement (compared to normal bowel loops)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Disease Status for imaged section
Time Frame: 2 years
status of inactive, mild activity, moderate activity and severe activity
2 years
Degree of mesenteric inflammation
Time Frame: 2 years
Inflammation assessed as none, mild, moderate, severe
2 years
Maximum Bowel Wall Thickness
Time Frame: 2 years
Measured
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Jonathan Dillman, MD,MSc, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2020

Primary Completion (Actual)

June 12, 2024

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 11, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIN_Lumason Crohns_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Research data including identifying information about participants will only be accessible to CCHMC study personnel. De-identified data including images will be shared with scientists at Bracco Diagnostics. No identifiable data will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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