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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of bowel wall enhancement | Percent hyperenhancement (compared to normal bowel loops) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Disease Status for imaged section | status of inactive, mild activity, moderate activity and severe activity | 2 years |
| Degree of mesenteric inflammation | Inflammation assessed as none, mild, moderate, severe |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Dillman, MD,MSc | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21710535 | Background | 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. | |
| 20449794 |
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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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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| 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 |
|
| 2 years |
| Maximum Bowel Wall Thickness | Measured | 2 years |
| 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. |
| 19070446 | 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. |
| 21830051 | 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. |
| 22157203 | 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. |
| 21439749 | 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. |
| 19635834 | 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. |
| 22271005 | 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. |
| 22698508 | 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. |
| 21273775 | 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. |
| 23001574 | 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. |
| 19064035 | 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. |
| 22249601 | 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. |
| 17515388 | 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. |
| 17392249 | 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. |
| D007410 | Intestinal Diseases |