Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2018-05-09
2025-12-31
Brief Summary
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Detailed Description
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This is a prospective study of children less than 8 years of age who are clinically stable and undergoing an abdominal CT with IV contrast as part of their clinical care due to concerns for abdominal trauma. Investigators will compare CEUS results with those obtained by CT. Investigators will additionally include retrospective data of children who underwent both abdominal CT and CEUS as part of clinical care.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Retrospective Review
Comparison of CT and CEUS results from retrospective chart review of children who have had a CEUS for trauma at the Children's Hospital of Philadelphia (CHOP).
No interventions assigned to this group
Prospective Observation
Prospective observation of comparison of CT and CEUS results among children who are undergoing a CEUS and abdominal CT as part of clinical care.
No interventions assigned to this group
Contrast-Enhanced Ultrasound using Lumason
Prospective intervention using contrast enhanced ultrasound with IV contrast Lumason.
Contrast-Enhanced Ultrasound using Lumason
Subjects will undergo a contrast enhanced ultrasound (CEUS) during which a standard greyscale abdominal ultrasound is performed first followed by injection of intravenous contrast with Lumason, and completion of contrast-enhanced ultrasound
Interventions
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Contrast-Enhanced Ultrasound using Lumason
Subjects will undergo a contrast enhanced ultrasound (CEUS) during which a standard greyscale abdominal ultrasound is performed first followed by injection of intravenous contrast with Lumason, and completion of contrast-enhanced ultrasound
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinically stable (defined as not undergoing an emergent surgical procedure in the next hour)
3. Abdominal CT ordered or obtained
4. IV in place
1. Males or females \< 8 years of age at time of CEUS.
2. Clinical Team plans to perform CT or has performed CT as part of clinical care for abdominal trauma
3. Clinical Team plans to perform (or has performed) CEUS as part of clinical care
4. Date of CEUS after January 1, 2015
Exclusion Criteria
2. History of allergic reaction to Lumason, sulfa-hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na) palmitic acid)
3. Known congenital or acquired heart disease
0 Years
7 Years
ALL
Yes
Sponsors
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Children's Hospital of Philadelphia
OTHER
Responsible Party
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Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Wood J, Rubin DM, Nance ML, Christian CW. Distinguishing inflicted versus accidental abdominal injuries in young children. J Trauma. 2005 Nov;59(5):1203-8. doi: 10.1097/01.ta.0000196437.07011.b1.
Lutz N, Nance ML, Kallan MJ, Arbogast KB, Durbin DR, Winston FK. Incidence and clinical significance of abdominal wall bruising in restrained children involved in motor vehicle crashes. J Pediatr Surg. 2004 Jun;39(6):972-5. doi: 10.1016/j.jpedsurg.2004.02.029.
Carter KW, Moulton SL. Pediatric abdominal injury patterns caused by "falls": A comparison between nonaccidental and accidental trauma. J Pediatr Surg. 2016 Feb;51(2):326-8. doi: 10.1016/j.jpedsurg.2015.10.056. Epub 2015 Oct 31.
Cooper A, Floyd T, Barlow B, Niemirska M, Ludwig S, Seidl T, O'Neill J, Templeton J, Ziegler M, Ross A, et al. Major blunt abdominal trauma due to child abuse. J Trauma. 1988 Oct;28(10):1483-7. doi: 10.1097/00005373-198810000-00015.
Lindberg D, Makoroff K, Harper N, Laskey A, Bechtel K, Deye K, Shapiro R; ULTRA Investigators. Utility of hepatic transaminases to recognize abuse in children. Pediatrics. 2009 Aug;124(2):509-16. doi: 10.1542/peds.2008-2348. Epub 2009 Jul 20.
Lindberg DM, Shapiro RA, Blood EA, Steiner RD, Berger RP; ExSTRA investigators. Utility of hepatic transaminases in children with concern for abuse. Pediatrics. 2013 Feb;131(2):268-75. doi: 10.1542/peds.2012-1952. Epub 2013 Jan 14.
Trout AT, Strouse PJ, Mohr BA, Khalatbari S, Myles JD. Abdominal and pelvic CT in cases of suspected abuse: can clinical and laboratory findings guide its use? Pediatr Radiol. 2011 Jan;41(1):92-8. doi: 10.1007/s00247-010-1847-8. Epub 2010 Oct 9.
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Goske MJ, Applegate KE, Bulas D, Butler PF, Callahan MJ, Coley BD, Don S, Frush DP, Hernanz-Schulman M, Kaste SC, Morrison G, Sidhu M, Strauss KJ, Treves ST; Alliance for Radiation Safety in Pediatric Imaging. Image Gently: progress and challenges in CT education and advocacy. Pediatr Radiol. 2011 Sep;41 Suppl 2:461-6. doi: 10.1007/s00247-011-2133-0. Epub 2011 Aug 17.
Laugesen NG, Nolsoe CP, Rosenberg J. Clinical Applications of Contrast-Enhanced Ultrasound in the Pediatric Work-Up of Focal Liver Lesions and Blunt Abdominal Trauma: A Systematic Review. Ultrasound Int Open. 2017 Feb;3(1):E2-E7. doi: 10.1055/s-0042-124502.
Miele V, Piccolo CL, Trinci M, Galluzzo M, Ianniello S, Brunese L. Diagnostic imaging of blunt abdominal trauma in pediatric patients. Radiol Med. 2016 May;121(5):409-30. doi: 10.1007/s11547-016-0637-2. Epub 2016 Apr 13.
Catalano O, Aiani L, Barozzi L, Bokor D, De Marchi A, Faletti C, Maggioni F, Montanari N, Orlandi PE, Siani A, Sidhu PS, Thompson PK, Valentino M, Ziosi A, Martegani A. CEUS in abdominal trauma: multi-center study. Abdom Imaging. 2009 Mar-Apr;34(2):225-34. doi: 10.1007/s00261-008-9452-0.
Clevert DA, Weckbach S, Minaifar N, Clevert DA, Stickel M, Reiser M. Contrast-enhanced ultrasound versus MS-CT in blunt abdominal trauma. Clin Hemorheol Microcirc. 2008;39(1-4):155-69.
Manetta R, Pistoia ML, Bultrini C, Stavroulis E, Di Cesare E, Masciocchi C. Ultrasound enhanced with sulphur-hexafluoride-filled microbubbles agent (SonoVue) in the follow-up of mild liver and spleen trauma. Radiol Med. 2009 Aug;114(5):771-9. doi: 10.1007/s11547-009-0406-6. Epub 2009 May 30. English, Italian.
Thorelius L. Emergency real-time contrast-enhanced ultrasonography for detection of solid organ injuries. Eur Radiol. 2007 Dec;17 Suppl 6:F107-11. doi: 10.1007/s10406-007-0235-4.
Valentino M, Serra C, Zironi G, De Luca C, Pavlica P, Barozzi L. Blunt abdominal trauma: emergency contrast-enhanced sonography for detection of solid organ injuries. AJR Am J Roentgenol. 2006 May;186(5):1361-7. doi: 10.2214/AJR.05.0027.
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Oldenburg A, Hohmann J, Skrok J, Albrecht T. Imaging of paediatric splenic injury with contrast-enhanced ultrasonography. Pediatr Radiol. 2004 Apr;34(4):351-4. doi: 10.1007/s00247-003-1092-5. Epub 2003 Dec 2.
Valentino M, Serra C, Pavlica P, Labate AM, Lima M, Baroncini S, Barozzi L. Blunt abdominal trauma: diagnostic performance of contrast-enhanced US in children--initial experience. Radiology. 2008 Mar;246(3):903-9. doi: 10.1148/radiol.2463070652. Epub 2008 Jan 14.
Menichini G, Sessa B, Trinci M, Galluzzo M, Miele V. Accuracy of contrast-enhanced ultrasound (CEUS) in the identification and characterization of traumatic solid organ lesions in children: a retrospective comparison with baseline US and CE-MDCT. Radiol Med. 2015 Nov;120(11):989-1001. doi: 10.1007/s11547-015-0535-z. Epub 2015 Mar 31.
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Piskunowicz M, Kosiak W, Batko T, Piankowski A, Polczynska K, Adamkiewicz-Drozynska E. Safety of intravenous application of second-generation ultrasound contrast agent in children: prospective analysis. Ultrasound Med Biol. 2015 Apr;41(4):1095-9. doi: 10.1016/j.ultrasmedbio.2014.11.003. Epub 2015 Feb 18.
Yusuf GT, Sellars ME, Deganello A, Cosgrove DO, Sidhu PS. Retrospective Analysis of the Safety and Cost Implications of Pediatric Contrast-Enhanced Ultrasound at a Single Center. AJR Am J Roentgenol. 2017 Feb;208(2):446-452. doi: 10.2214/AJR.16.16700. Epub 2016 Dec 13.
Jacob J, Deganello A, Sellars ME, Hadzic N, Sidhu PS. Contrast enhanced ultrasound (CEUS) characterization of grey-scale sonographic indeterminate focal liver lesions in pediatric practice. Ultraschall Med. 2013 Dec;34(6):529-40. doi: 10.1055/s-0033-1355785. Epub 2013 Oct 16.
Bonini G, Pezzotta G, Morzenti C, Agazzi R, Nani R. Contrast-enhanced ultrasound with SonoVue in the evaluation of postoperative complications in pediatric liver transplant recipients. J Ultrasound. 2007 Jun;10(2):99-106. doi: 10.1016/j.jus.2007.02.008. Epub 2007 Jun 13.
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Rafailidis V, Deganello A, Watson T, Sidhu PS, Sellars ME. Enhancing the role of paediatric ultrasound with microbubbles: a review of intravenous applications. Br J Radiol. 2017 Jan;90(1069):20160556. doi: 10.1259/bjr.20160556. Epub 2016 Sep 26.
Other Identifiers
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17-014183
Identifier Type: -
Identifier Source: org_study_id