Application of a second-generation US contrast agent in infants and children—a European questionnaire-based survey

Abstract

Background No US contrast agent (US-CA) is currently licensed for use in children.Objective To survey the off-label use in children of a second-generation US-CA. Materials and methods Questionnaires were e-mailed to European paediatric radiologists, who were asked about their experience with the second-generation US-CA Sonovue® (Bracco, Milan, Italy). Number of examinations per indication and adverse effects were recorded. Examinations were categorised by intravenous or intracavitary use of US-CA. Results Out of 146 respondents, 88 stated that they did not perform contrast-enhanced US in children, but 36 of these (44%) would appreciate paediatric approval. Fortyfive centres reported 5,079 examinations in children (age mean: 2.9 years; range: birth-18 years, M/F: 1/ 2.8). The majority (4,131 [81%] in 29 centres) were intravesical applications. The minority (948 [19%] in 30 centres) were intravenous applications. No adverse effects had been recorded from intravesical use. Six minor adverse effects (skin reaction, unusual taste, hyperventilation) had been recorded after five intravenous studies (0.52%). Conclusion Responses suggest a favourable safety profile of this second-generation US-CA in children. It also demonstrates a demand for such US-CA from paediatric radiologists.

Contrast-enhanced voiding urosonography (ceVUS) as a diagnostic tool in evaluation of vesicoureteral reflux

“…In a recent European survey, there were no allergic reactions or adverse events related to SonoVue in 5079 paediatric ceVUS examinations performed in 45 European centres (43). Only a few minor adverse events related to catheterization were encountered.…”

Enhancing the role of paediatric ultrasound with microbubbles: a review of intravenous applications

“…These reactions affected the skin, taste and respiratory frequency. 27 In a series of 37 paediatric patients undergoing CEUS for various reasons including lesion characterization, trauma and infection, there was only 1 child who reported self-limiting nausea requiring no treatment.…”

“…22 In the paediatric population, limited studies evaluated the safety profile of ultrasonography contrast agents. [23][24][25][26][27][28] The largest series involved 167 CEUS examinations using SonoVue™ in 137 children, which documented 1 (0.6%) severe allergic reaction. However, no other haemodynamic and oxygenation status changes were documented in this study, and no other subjective complaints were recorded following the CEUS examination.…”

“…Although representing an "off-label" use of CEUS in Europe, unlike in the USA, the liver is the most frequently examined organ and FLL characterization the commonest indication for paediatric CEUS examinations. 27,49 A small number of studies dedicated to the characterization of paediatric FLL are available. One study evaluated CEUS in 44 children with inconclusive greyscale FLL having consensus multimodality imaging or histology as reference method.…”

Contrast-enhanced ultrasonography in children

“…In some children some minor adverse reactions (urtica and rash, a brief alteration of taste sensation, mild tinnitus, light-headedness) were recorded. The European survey and meta-analysis of Darge et al evaluated the intravesical use of UCA in more than 7000 children (13,5). Only 0.8% transient adverse events were described, such as dysuria, hematuria, urinary retention, urinary tract infection, perianal irritation, abdominal or urethral discomfort etc.…”