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Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason

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ClinicalTrials.gov Identifier: NCT03492944
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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

Condition or disease Intervention/treatment
Crohn Disease Drug: Ultrasound Microbubble Contrast Agent Device: Ultrasound Imaging

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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI Enterography
Actual Study Start Date : March 6, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Degree of bowel wall enhancement [ Time Frame: 2 years ]
    Percent hyperenhancement (compared to normal bowel loops)


Secondary Outcome Measures :
  1. Overall Disease Status for imaged section [ Time Frame: 2 years ]
    status of inactive, mild activity, moderate activity and severe activity

  2. Degree of mesenteric inflammation [ Time Frame: 2 years ]
    Inflammation assessed as none, mild, moderate, severe

  3. Maximum Bowel Wall Thickness [ Time Frame: 2 years ]
    Measured



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492944


Contacts
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Contact: Becky Imbus, BA 513-636-9403 rebecca.imbus@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Principal Investigator: Jonathan Dillman, MD, MSc         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Jonathan Dillman, MD,MSc Children's Hospital Medical Center, Cincinnati
Publications:

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03492944    
Other Study ID Numbers: CIN_Lumason Crohns_001
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases