Ultrasound contrast media in paediatric patients: Is it an off-label use? Regulatory requirements and radiologist's liability;Il mezzo di contrasto ecografico in età pediatrica: Uso off-label? Presupposti normativi e responsabilità del radiologo

Radiologia Medica

Volumn 117, Issue 1, 2012, Pages 148-159

  Esposito, F ^a   Di Serafino, M ^b   Sgambati, P ^b   Mercogliano, F ^c   Tarantino, L ^d   Vallone, G ^b   Oresta, P ^a  

^a SANTOBONO PAUSILIPON CHILDREN S HOSPITAL   (Italy)

^b UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^c Studio Legale Associato 'Mercoglianoandcelestino'   (Italy)

^d Nuovo Ospedale S Giovanni di Dio   (Italy)

Author keywords

Children; Off label; Ultrasound; Ultrasound contrast media

Indexed keywords

CONTRAST MEDIUM; DIAGNOSTIC AGENT;

ARTICLE; CLINICAL PRACTICE; ECHOGRAPHY; HUMAN; ITALY; LEGAL ASPECT; LEGAL LIABILITY; OFF LABEL DRUG USE; PEDIATRICS; STATISTICS;

CONTRAST MEDIA; HUMANS; ITALY; LIABILITY, LEGAL; OFF-LABEL USE; PEDIATRICS; PHYSICIAN'S PRACTICE PATTERNS; ULTRASONOGRAPHY;

EID: 84857651430     PISSN: 00338362     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11547-011-0718-1     Document Type: Article

References (32)

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 2-14
2. J.M. Correas L. Bridal A. Lesavre, et al. 2001 Ultrasound contrast agents: properties, principles of action, tolerance and artifacts Eur Radiol 11 1316 1328 11519538 10.1007/s003300100940 1:STN:280:DC%2BD3Mvns1ajtQ%3D%3D (Pubitemid 32755614)
3. M. Claudon D. Cosgrove T. Albrecht, et al. 2008 Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) - update 2008 Ultraschall Med 29 28 44 18270887 10.1055/s-2007-963785 1:STN:280:DC%2BD1c7htlensw%3D%3D (Pubitemid 351294171)
4. M. Fraquelli A. Colli G. Casazza, et al. 2005 Role of US in detection of Crohn disease: meta-analysis Radiology 236 95 101 15987966 10.1148/radiol. 2361040799 (Pubitemid 40853300)
5. A. Oldenburg J. Hohmann J. Skrok T. Albrecht 2004 Imaging of pediatric splenic injury with contrast-enhanced ultrasonography Pediatr Radiol. 34 351 354 14652701 10.1007/s00247-003-1092-5 (Pubitemid 38477311)
6. Foglietto illustrativo (2008) SonoVue. Bracco Imaging S.p.A., Colleretto Giacosa (TO)
7. M. Claudon F. Tranquart, et al. 2002 Advances in ultrasound Eur Radiol 12 7 18 11868070 10.1007/s00330-001-1185-1 (Pubitemid 36940020)
8. C.J. Das S. Dhingra A.K. Gupta, et al. 2009 Imaging of paediatric liver tumours with pathological correlation Clin Radiol 64 1015 1025 19748008 10.1016/j.crad.2009.04.014 1:STN:280:DC%2BD1MnhvFaqug%3D%3D
9. T.A. Whittingham 1999 An overview of digital technology in ultrasonic imaging Eur Radiol 9 Suppl3 S307 S311 10602916 10.1007/PL00014058
10. P. Hill 2005 Off licence and off-label prescribing in children: litigation fears for physicians Arch Dis Child 90 Suppl1 i17 i18 15665151 10.1136/adc.2004.058867 (Pubitemid 40187997)
11. Regolamento (CE) n. 1901/2006 Pubblicato nella G.U.U.E. 27 dicembre 2006, n. L.378
12. Bollettino di Informazione sul Farmaco XIII N.3 2006
13. K. Darge R.T. Moeller A. Trusen 2005 Diagnosis of vesicoureteric reflux with low-dose contrast-enhanced harmonic ultrasound imaging Pediatr Radiol 35 73 78 15448949 10.1007/s00247-004-1317-2 (Pubitemid 40796265)
14. T. Berrocal F. Gavrà A. Arjonilla 2005 Vesicoureteral reflux: can the urethra be adequately assessed by using contrast-enhanced voiding US of the bladder? Radiology 234 235 241 15618383 10.1148/radiol.2341031503 (Pubitemid 39658390)
15. F. Papadopoulou A. Anthopoulou E. Siomou, et al. 2009 Harmonic voiding urosonography with a second-generation contrast agent for the diagnosis of vesicoureteral reflux Pediatr Radiol 39 239 244 19096835 10.1007/s00247-008- 1080-x
16. K. Vassiou M. Vlychou R. Moisidou, et al. 2004 Contrast-enhanced sonographic detection of vesicoureteral reflux in children: comparison with voiding cystourethrography Rofo 176 1453 1457 15383977 10.1055/s-2004-813170 1:STN:280:DC%2BD2cvntlWjsg%3D%3D (Pubitemid 39382291)
17. G. Ascenti G. Zimbaro S. Mazziotti, et al. 2003 Vesicoureteral reflux: comparison between urosonography and radionuclide cystography Pediatr Nephrol 18 768 771 12802637 10.1007/s00467-003-1130-4 (Pubitemid 36949962)
18. M. Valentino M.R. Rimondi A. Gentili, et al. 2004 L'ecografia con mezzo di contrasto nel management dei traumi splenici in età pediatrica Giornale Italiano di Ecografia 7 205 208
19. M. Valentino S.S. Galloni M.R. Rimondi, et al. 2006 Contrast-enhanced ultrasound in non-operative management of pancreatic injury in childhood Pediatr Radiol 36 558 560 16601976 10.1007/s00247-006-0157-7
20. M. Valentino C. Serra P. Pavlica, et al. 2008 Blunt abdominal trauma: diagnostic performance of contrast-enhanced US in children-initial experience Radiology 246 903 909 18195385 10.1148/radiol.2463070652
21. R. Farina F. Pennisi M. La Rosa, et al. 2008 Contrast-enhanced colour-Doppler sonography versus pH-metry in the diagnosis of gastro-oesophageal reflux in children Radiol Med 113 591 598 18478190 10.1007/s11547-008-0267-4 1:STN:280:DC%2BD1crgs1Ogtg%3D%3D
22. T. Hamada M. Tanak Y. Hashimoto, et al. 2006 Contrast-enhanced sonographic findings of gangrenous Meckel diverticulitis J Ultrasound Med 25 1227 1231 16929027 (Pubitemid 44316273)
23. C. Görg J. Egbring T. Bert 2009 Contrast-enhanced ultrasound of epiploic appendagitis Ultraschall Med 30 163 167 19253206 10.1055/s-2008-1027891
24. A.S. Doria R. Guarniero F.G. Cunha, et al. 2002 Contrast-enhanced power Doppler sonography: assessment of revascularization flow in Legg-Calvé- Perthes' disease Ultrasound Med Biol 28 171 11937279 10.1016/S0301-5629(01) 00500-2 (Pubitemid 34286413)
25. L. Incesu A.K. Yazicioglu M.B. Selcuk N. Ozen 2004 Contrast-enhanced power Doppler US in the diagnosis of acute appendicitis Eur J Radiol 50 201 209 15081132 10.1016/S0720-048X(03)00102-5 1:STN:280:DC%2BD2c7osFOhuw%3D%3D (Pubitemid 38469969)
26. M. Valentino 2006 Utilità dell'ecografia con mezzo di contrasto nella patologia gastrointestinale acuta Giornale Italiano di Ecografia 9 121 126
27. Y. Wang Y. Wang Y. Wang, et al. 2007 Intraoperative real-time contrast-enhanced ultrasound angiography: a new adjunct in the surgical treatment of arteriovenous malformations J Neurosurg 107 959 964 17977267 10.3171/JNS-07/11/0959 (Pubitemid 350255209)
28. C. Greis 2009 Ultrasound contrast agents as markers of vascularity and microcirculation Clin Hemorheol Microcirc 43 1 9 19713597
29. M.B. McCarville 2008 New frontiers in pediatric oncologic imaging Cancer Imaging 25 87 92 10.1102/1470-7330.2008.0012 (Pubitemid 351514014)
30. H. Moschouris K. Stamatiou E. Lampropoulou, et al. 2009 Imaging of the acute scrotum: Is there a place for contrast-enhanced ultrasonography? Int Braz J Urol 35 692 705 20028575 10.1590/S1677-55382009000600008 1:STN:280: DC%2BD1MfktVWmtw%3D%3D
31. Vinci P (2008) La prescrizione dei farmaci off-label. http://www.paolovinci.it/pdf/Pubblicazioni-2008- Relazione-Farmaci-off
32. O. Tamburrini I. Aprile C. Falcone, et al. 2011 Off-label use of intravascular iodinated organic and MR contrast media Radiol Med 116 1 14 20981503 10.1007/s11547-010-0601-5 1:STN:280:DC%2BC3M3ptlemsw%3D%3D