Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason

NCT03492944 | Active Not Recruiting FDA Drug FDA Device

• 1 other identifier: CIN_Lumason Crohns_001
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Degree of bowel wall enhancement

  Percent hyperenhancement (compared to normal bowel loops)

  2 years

Secondary Outcomes (3)

• Overall Disease Status for imaged section

  2 years

• Degree of mesenteric inflammation

  2 years

• Maximum Bowel Wall Thickness

  2 years

Study Arms (1)

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; Device: Ultrasound Imaging

Interventions

Ultrasound Microbubble Contrast Agent DRUG

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

Also known as: Lumason

Ultrasound Microbubble Contrast Agent

Ultrasound Imaging DEVICE

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

Ultrasound Microbubble Contrast Agent

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (15)

• Adler J, Punglia DR, Dillman JR, Polydorides AD, Dave M, Al-Hawary MM, Platt JF, McKenna BJ, Zimmermann EM. Computed tomography enterography findings correlate with tissue inflammation, not fibrosis in resected small bowel Crohn's disease. Inflamm Bowel Dis. 2012 May;18(5):849-56. doi: 10.1002/ibd.21801. Epub 2011 Jun 24.

  PMID: 21710535 BACKGROUND

• Girlich C, Jung EM, Huber E, Ott C, Iesalnieks I, Schreyer A, Schacherer D. Comparison between preoperative quantitative assessment of bowel wall vascularization by contrast-enhanced ultrasound and operative macroscopic findings and results of histopathological scoring in Crohn's disease. Ultraschall Med. 2011 Apr;32(2):154-9. doi: 10.1055/s-0029-1245398. Epub 2010 May 6.

  PMID: 20449794 BACKGROUND

• Quaia E, Migaleddu V, Baratella E, Pizzolato R, Rossi A, Grotto M, Cova MA. The diagnostic value of small bowel wall vascularity after sulfur hexafluoride-filled microbubble injection in patients with Crohn's disease. Correlation with the therapeutic effectiveness of specific anti-inflammatory treatment. Eur J Radiol. 2009 Mar;69(3):438-44. doi: 10.1016/j.ejrad.2008.10.029. Epub 2008 Dec 12.

  PMID: 19070446 BACKGROUND

• Wong DD, Forbes GM, Zelesco M, Mason R, Pawlik J, Mendelson RM. Crohn's disease activity: quantitative contrast-enhanced ultrasound assessment. Abdom Imaging. 2012 Jun;37(3):369-76. doi: 10.1007/s00261-011-9792-z.

  PMID: 21830051 BACKGROUND

• De Franco A, Di Veronica A, Armuzzi A, Roberto I, Marzo M, De Pascalis B, De Vitis I, Papa A, Bock E, Danza FM, Bonomo L, Guidi L. Ileal Crohn disease: mural microvascularity quantified with contrast-enhanced US correlates with disease activity. Radiology. 2012 Feb;262(2):680-8. doi: 10.1148/radiol.11110440. Epub 2011 Dec 12.

  PMID: 22157203 BACKGROUND

• Girlich C, Schacherer D, Jung EM, Schreyer A, Buttner R. Comparison between a clinical activity index (Harvey-Bradshaw-Index), laboratory inflammation markers and quantitative assessment of bowel wall vascularization by contrast-enhanced ultrasound in Crohn's disease. Eur J Radiol. 2012 Jun;81(6):1105-9. doi: 10.1016/j.ejrad.2011.02.054. Epub 2011 Mar 24.

  PMID: 21439749 BACKGROUND

• Ripolles T, Martinez MJ, Paredes JM, Blanc E, Flors L, Delgado F. Crohn disease: correlation of findings at contrast-enhanced US with severity at endoscopy. Radiology. 2009 Oct;253(1):241-8. doi: 10.1148/radiol.2531082269. Epub 2009 Jul 27.

  PMID: 19635834 BACKGROUND

• Malago R, D'Onofrio M, Mantovani W, D'Alpaos G, Foti G, Pezzato A, Caliari G, Cusumano D, Benini L, Pozzi Mucelli R. Contrast-enhanced ultrasonography (CEUS) vs. MRI of the small bowel in the evaluation of Crohn's disease activity. Radiol Med. 2012 Mar;117(2):268-81. doi: 10.1007/s11547-011-0783-5. Epub 2012 Jan 21.

  PMID: 22271005 BACKGROUND

• Quaia E, De Paoli L, Stocca T, Cabibbo B, Casagrande F, Cova MA. The value of small bowel wall contrast enhancement after sulfur hexafluoride-filled microbubble injection to differentiate inflammatory from fibrotic strictures in patients with Crohn's disease. Ultrasound Med Biol. 2012 Aug;38(8):1324-32. doi: 10.1016/j.ultrasmedbio.2012.04.008. Epub 2012 Jun 13.

  PMID: 22698508 BACKGROUND

• Schirin-Sokhan R, Winograd R, Tischendorf S, Wasmuth HE, Streetz K, Tacke F, Trautwein C, Tischendorf JJ. Assessment of inflammatory and fibrotic stenoses in patients with Crohn's disease using contrast-enhanced ultrasound and computerized algorithm: a pilot study. Digestion. 2011;83(4):263-8. doi: 10.1159/000321389. Epub 2011 Jan 28.

  PMID: 21273775 BACKGROUND

• Riccabona M, Avni FE, Damasio MB, Ording-Muller LS, Blickman JG, Darge K, Lobo ML, Papadopoulou F, Vivier PH, Willi U. ESPR Uroradiology Task Force and ESUR Paediatric Working Group--Imaging recommendations in paediatric uroradiology, part V: childhood cystic kidney disease, childhood renal transplantation and contrast-enhanced ultrasonography in children. Pediatr Radiol. 2012 Oct;42(10):1275-83. doi: 10.1007/s00247-012-2436-9. Epub 2012 Sep 22.

  PMID: 23001574 BACKGROUND

• Main ML, Ryan AC, Davis TE, Albano MP, Kusnetzky LL, Hibberd M. Acute mortality in hospitalized patients undergoing echocardiography with and without an ultrasound contrast agent (multicenter registry results in 4,300,966 consecutive patients). Am J Cardiol. 2008 Dec 15;102(12):1742-6. doi: 10.1016/j.amjcard.2008.08.019. Epub 2008 Oct 23.

  PMID: 19064035 BACKGROUND

• McCarville MB, Kaste SC, Hoffer FA, Khan RB, Walton RC, Alpert BS, Furman WL, Li C, Xiong X. Contrast-enhanced sonography of malignant pediatric abdominal and pelvic solid tumors: preliminary safety and feasibility data. Pediatr Radiol. 2012 Jul;42(7):824-33. doi: 10.1007/s00247-011-2338-2. Epub 2012 Jan 17.

  PMID: 22249601 BACKGROUND

• Dillman JR, Strouse PJ, Ellis JH, Cohan RH, Jan SC. Incidence and severity of acute allergic-like reactions to i.v. nonionic iodinated contrast material in children. AJR Am J Roentgenol. 2007 Jun;188(6):1643-7. doi: 10.2214/AJR.06.1328.

  PMID: 17515388 BACKGROUND

• Wang CL, Cohan RH, Ellis JH, Adusumilli S, Dunnick NR. Frequency, management, and outcome of extravasation of nonionic iodinated contrast medium in 69,657 intravenous injections. Radiology. 2007 Apr;243(1):80-7. doi: 10.1148/radiol.2431060554.

  PMID: 17392249 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jonathan Dillman, MD,MSc

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: April 10, 2018
• Study Start: March 6, 2020
• Primary Completion: June 12, 2024
• Study Completion: February 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)