Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03492944
• Other study ID #: CIN_Lumason Crohns_001
• Status: Active, not recruiting
• Start date: March 6, 2020
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: January 2025
• Est. primary completion date: June 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. Erratum In: AJR Am J Roentgenol. 2007 Sep;189(3):512. — View Citation

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. Erratum In: Ultraschall Med. 2011 Dec;32 Suppl 2:E1. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Radiology. 2015 Jan;274(1):307. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of bowel wall enhancement	Percent hyperenhancement (compared to normal bowel loops)	2 years
Secondary	Overall Disease Status for imaged section	status of inactive, mild activity, moderate activity and severe activity	2 years
Secondary	Degree of mesenteric inflammation	Inflammation assessed as none, mild, moderate, severe	2 years
Secondary	Maximum Bowel Wall Thickness	Measured	2 years