La radiologia medica

, Volume 117, Issue 1, pp 148–159 | Cite as

Ultrasound contrast media in paediatric patients: is it an off-label use? Regulatory requirements and radiologist’s liability

  • F. Esposito
  • M. Di Serafino
  • P. Sgambati
  • F. Mercogliano
  • L. Tarantino
  • G. Vallone
  • P. Oresta
Paediatric Radiology / Radiologia Pediatrica

Abstract

The use of ultrasound contrast media is yet to be validated in children. The rare reports in the scientific literature denote their “sporadic” and “experimental” use. Their most likely use is in the setting of off-label prescription of medications. As there are still no guidelines available in Italy for the off-label use of medications, we aim to define the duties, obligations and liability of ultrasound radiologists according to the laws in force.

Keywords

Ultrasound Ultrasound contrast media Off label Children 

Il mezzo di contrasto ecografico in età pediatrica: uso off-label? Presupposti normativi e responsabilità del radiologo

Riassunto

L’utilizzo del mezzo di contrasto ecografico a tutt’oggi non risulta ancora validato in età pediatrica. Le rare segnalazioni nella letteratura scientifica ne riportano un impiego sporadico e sperimentale. La sua utilizzazione è probabilmente da considerarsi nell’ambito delle prescrizioni dei farmaci off-label. Poiché in Italia per l’impiego dei farmaci off-label non sono ancora disponibili linee guida specifiche, si cerca di definire, secondo la normativa vigente, gli adempimenti, gli obblighi e le responsabilità del medico ecografista.

Parole chiave

Ecografia Mezzo di contrasto ecografico Off-label Pediatria 

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References/Bibliografia

  1. 1.
    Quaia E (2005) Classification and safety of microbubble-based contrast agents. In: Quaia E (ed) Contrast media in ultrasonography: basic principles and clinical applications. Springer, Berlin Heidelberg New York, pp 2–14CrossRefGoogle Scholar
  2. 2.
    Correas JM, Bridal L, Lesavre A et al (2001) Ultrasound contrast agents: properties, principles of action, tolerance and artifacts. Eur Radiol 11:1316–1328PubMedCrossRefGoogle Scholar
  3. 3.
    Claudon M, Cosgrove D, Albrecht T et al (2008) Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) — update 2008. Ultraschall Med 29:28–44PubMedCrossRefGoogle Scholar
  4. 4.
    Fraquelli M, Colli A, Casazza G et al (2005) Role of US in detection of Crohn disease: meta-analysis. Radiology 236:95–101PubMedCrossRefGoogle Scholar
  5. 5.
    Oldenburg A, Hohmann J, Skrok J, Albrecht T (2004) Imaging of pediatric splenic injury with contrast-enhanced ultrasonography. Pediatr Radiol. 34:351–354PubMedCrossRefGoogle Scholar
  6. 6.
    Foglietto illustrativo (2008) SonoVue. Bracco Imaging S.p.A., Colleretto Giacosa (TO)Google Scholar
  7. 7.
    Claudon M, Tranquart F et al (2002) Advances in ultrasound. Eur Radiol 12:7–18PubMedCrossRefGoogle Scholar
  8. 8.
    Das CJ, Dhingra S, Gupta AK et al (2009) Imaging of paediatric liver tumours with pathological correlation. Clin Radiol 64:1015–1025PubMedCrossRefGoogle Scholar
  9. 9.
    Whittingham TA (1999) An overview of digital technology in ultrasonic imaging. Eur Radiol 9(Suppl 3):S307–S311PubMedCrossRefGoogle Scholar
  10. 10.
    Hill P (2005) Off licence and off-label prescribing in children: litigation fears for physicians. Arch Dis Child 90Suppl 1:i17–i18PubMedCrossRefGoogle Scholar
  11. 11.
    Regolamento (CE) n. 1901/2006 Pubblicato nella G.U.U.E. 27 dicembre 2006, n. L.378Google Scholar
  12. 12.
    Bollettino di Informazione sul Farmaco XIII N.3 2006Google Scholar
  13. 13.
    Darge K, Moeller RT, Trusen A (2005) Diagnosis of vesicoureteric reflux with low-dose contrast-enhanced harmonic ultrasound imaging. Pediatr Radiol 35:73–78PubMedCrossRefGoogle Scholar
  14. 14.
    Berrocal T, Gavrà F, Arjonilla A (2005) Vesicoureteral reflux: can the urethra be adequately assessed by using contrast-enhanced voiding US of the bladder? Radiology 234:235–241PubMedCrossRefGoogle Scholar
  15. 15.
    Papadopoulou F, Anthopoulou A, Siomou E et al (2009) Harmonic voiding urosonography with a second-generation contrast agent for the diagnosis of vesicoureteral reflux. Pediatr Radiol 39:239–244PubMedCrossRefGoogle Scholar
  16. 16.
    Vassiou K, Vlychou M, Moisidou R et al (2004) Contrast-enhanced sonographic detection of vesicoureteral reflux in children: comparison with voiding cystourethrography. Rofo 176:1453–1457PubMedCrossRefGoogle Scholar
  17. 17.
    Ascenti G, Zimbaro G, Mazziotti S et al (2003) Vesicoureteral reflux: comparison between urosonography and radionuclide cystography. Pediatr Nephrol 18:768–771PubMedCrossRefGoogle Scholar
  18. 18.
    Valentino M, Rimondi MR, Gentili A et al (2004) L’ecografia con mezzo di contrasto nel management dei traumi splenici in età pediatrica. Giornale Italiano di Ecografia 7:205–208Google Scholar
  19. 19.
    Valentino M, Galloni SS, Rimondi MR et al (2006) Contrast-enhanced ultrasound in non-operative management of pancreatic injury in childhood. Pediatr Radiol 36:558–560PubMedCrossRefGoogle Scholar
  20. 20.
    Valentino M, Serra C, Pavlica P et al (2008) Blunt abdominal trauma: diagnostic performance of contrast-enhanced US in children—initial experience. Radiology 246:903–909PubMedCrossRefGoogle Scholar
  21. 21.
    Farina R, Pennisi F, La Rosa M et al (2008) Contrast-enhanced colour-Doppler sonography versus pH-metry in the diagnosis of gastro-oesophageal reflux in children. Radiol Med 113:591–598PubMedCrossRefGoogle Scholar
  22. 22.
    Hamada T, Tanak M, Hashimoto Y et al (2006) Contrast-enhanced sonographic findings of gangrenous Meckel diverticulitis. J Ultrasound Med 25:1227–1231PubMedGoogle Scholar
  23. 23.
    Görg C, Egbring J, Bert T (2009) Contrast-enhanced ultrasound of epiploic appendagitis. Ultraschall Med 30:163–167PubMedCrossRefGoogle Scholar
  24. 24.
    Doria AS, Guarniero R, Cunha FG et al (2002) Contrast-enhanced power Doppler sonography: assessment of revascularization flow in Legg-Calvé-Perthes’ disease. Ultrasound Med Biol 28:171:182PubMedCrossRefGoogle Scholar
  25. 25.
    Incesu L, Yazicioglu AK, Selcuk MB, Ozen N (2004) Contrast-enhanced power Doppler US in the diagnosis of acute appendicitis. Eur J Radiol 50:201–209PubMedCrossRefGoogle Scholar
  26. 26.
    Valentino M (2006) Utilità dell’ecografia con mezzo di contrasto nella patologia gastrointestinale acuta. Giornale Italiano di Ecografia 9:121–126Google Scholar
  27. 27.
    Wang Y, Wang Y, Wang Y et al (2007) Intraoperative real-time contrast-enhanced ultrasound angiography: a new adjunct in the surgical treatment of arteriovenous malformations. J Neurosurg 107:959–964PubMedCrossRefGoogle Scholar
  28. 28.
    Greis C (2009) Ultrasound contrast agents as markers of vascularity and microcirculation. Clin Hemorheol Microcirc 43:1–9PubMedGoogle Scholar
  29. 29.
    McCarville MB (2008) New frontiers in pediatric oncologic imaging. Cancer Imaging 25:87–92CrossRefGoogle Scholar
  30. 30.
    Moschouris H, Stamatiou K, Lampropoulou E et al (2009) Imaging of the acute scrotum: Is there a place for contrast-enhanced ultrasonography? Int Braz J Urol 35:692–705PubMedCrossRefGoogle Scholar
  31. 31.
  32. 32.
    Tamburrini O, Aprile I, Falcone C et al (2011) Off-label use of intravascular iodinated organic and MR contrast media. Radiol Med 116:1–14PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Italia 2011

Authors and Affiliations

  • F. Esposito
    • 1
  • M. Di Serafino
    • 2
  • P. Sgambati
    • 2
  • F. Mercogliano
    • 3
  • L. Tarantino
    • 4
  • G. Vallone
    • 2
  • P. Oresta
    • 1
  1. 1.Struttura Complessa di RadiologiaAzienda Ospedaliera Pediatrica “Santobono-Pausilipon”NapoliItaly
  2. 2.DAS Diagnostica per Immagini e RadioterapiaUniversità “Federico II”NapoliItaly
  3. 3.Studio legale associato “Mercogliano&Celestino”RossanoItaly
  4. 4.U.O. di Epatologia ed Ecointerventistica, ASL NA3Ospedale S. Giovanni di DioFrattamaggioreItaly

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