Contrast-enhanced voiding urosonography (ceVUS) with the intravesical administration of the ultrasound contrast agent Optison™ for vesicoureteral reflux detection in children: a prospective clinical trial.
Background: Contrast-enhanced voiding urosonography (ceVUS) is widely used outside the United States to diagnose vesicoureteral reflux (VUR) in children and is highly sensitive while avoiding exposure to ionizing radiation. At the onset of this study, two ultrasound (US) contrast agents were availab...
| Publicado en: | Pediatric Radiology Vol. 48; no. 2; pp. 216 - 227 |
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| Autores principales: | , , , , , , , , , , , |
| Formato: | clinical trial research Journal Article |
| Publicado: |
Springer Nature
Feb2018
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=127735455&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 127735455 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 03010449 O03 jtl: Pediatric Radiology issn: 03010449 maglogo: N pubinfo: dt: Feb2018 vid: 48 iid: 2 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 127735455 127735455 143993047 NLM29181582 127735455 10.1007/s00247-017-4026-3 NLM29181582 127735455 ppf: 216 ppct: 11 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Contrast-enhanced voiding urosonography (ceVUS) with the intravesical administration of the ultrasound contrast agent Optison™ for vesicoureteral reflux detection in children: a prospective clinical trial. aug: au: Ntoulia, Aikaterini Back, Susan J. Shellikeri, Sphoorti Poznick, Laura Morgan, Trudy Kerwood, Joanne Christopher Edgar, J. Bellah, Richard D. Reid, Janet R. Jaramillo, Diego Canning, Douglas A. Darge, Kassa affil: Department of Radiology, The Children’s Hospital of Philadelphia, 34th Street & Civic Center Boulevard, 19104, Philadelphia, PA, USA sug: subj: Albumins Administration and Dosage Vesicoureteral Reflux Fluorocarbons Administration and Dosage Contrast Media Administration and Dosage Administration, Intravesical Human Sensitivity and Specificity Prospective Studies Child, Preschool Child Female Infant Adolescence Male Clinical Trials Validation Studies Comparative Studies Evaluation Research Multicenter Studies Scales Child, Preschool: 2-5 years Child: 6-12 years Infant: 1-23 months Adolescent: 13-18 years Female Male ab: Background: Contrast-enhanced voiding urosonography (ceVUS) is widely used outside the United States to diagnose vesicoureteral reflux (VUR) in children and is highly sensitive while avoiding exposure to ionizing radiation. At the onset of this study, two ultrasound (US) contrast agents were available in the United States. Pediatric safety data for intravenous administration was published for one, Optison™.Objective: This study aimed to evaluate the diagnostic performance and safety of ceVUS using Optison™ and compare its diagnostic efficacy with voiding cystourethrogram (VCUG) for VUR detection and grading in children.Materials and Methods: The United States Food and Drug Administration and institutional Investigational New Drug authorizations were obtained to conduct a prospective comparative study of ceVUS with Optison™ and VCUG. CeVUS was performed with intravesical administration of 0.2% Optison™/normal saline solution. A standard VCUG followed. Safety assessment included physical examination, and heart rate, pulse oximetry and adverse reactions monitoring before, during and immediately after the examinations. A follow-up questionnaire was completed by telephone 48-h after the studies.Results: Sixty-two pelviureteric units were studied in 30 patients with a mean age of 3.5 years (range: 0.1-17 years) including 21 girls and 9 boys. No severe adverse events occurred. All patients had normal heart rate and blood oxygenation saturation prior to, during and after the studies. At the 48-h follow-up, one patient (3.3%) reported transient dysuria. Taking the VCUG as the reference standard, ceVUS had a sensitivity of 91.7% (95%; confidence interval [CI]: 61.5%-99.8%) and specificity of 98% (95%; CI: 89.4%-99.9%). The concordance between ceVUS and VCUG for VUR detection and grading was 84.3% and 81.8%, respectively. VUR grades were discrepant in 4/11 refluxing pelviureteric units, with VCUG upgrading VUR in 2.Conclusion: Detection of VUR with Optison™ ceVUS was comparable to VCUG without exposure to ionizing radiation. CeVUS with Optison™ is a well-tolerated diagnostic procedure with a favorable safety profile. pubtype: Academic Journal doctype: clinical trial research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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