Aikaterini Ntoulia1, Susan J Back2,3, Sphoorti Shellikeri2, Laura Poznick2, Trudy Morgan2, Joanne Kerwood2, J Christopher Edgar2,3, Richard D Bellah2,3, Janet R Reid2,3, Diego Jaramillo2,3, Douglas A Canning3,4, Kassa Darge2,3. 1. Department of Radiology, The Children's Hospital of Philadelphia, 34th Street & Civic Center Boulevard, Philadelphia, PA, 19104, USA. ntouliaa@email.chop.edu. 2. Department of Radiology, The Children's Hospital of Philadelphia, 34th Street & Civic Center Boulevard, Philadelphia, PA, 19104, USA. 3. Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 4. Division of Urology, Department of Surgery, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Abstract
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.
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.
Authors: M Beth McCarville; Sue C Kaste; Fredric A Hoffer; Raja B Khan; R Christopher Walton; Bruce S Alpert; Wayne L Furman; Chenghong Li; Xiaoping Xiong Journal: Pediatr Radiol Date: 2012-01-17
Authors: Anush Sridharan; Misun Hwang; Shelby Kutty; M Beth McCarville; Harriet J Paltiel; Maciej Piskunowicz; Sphoorti Shellikeri; Elizabeth Silvestro; George A Taylor; Ryne A Didier Journal: Pediatr Radiol Date: 2021-05-15
Authors: Constantin A Marschner; Vincent Schwarze; Regina Stredele; Matthias F Froelich; Johannes Rübenthaler; Thomas Geyer; Dirk-André Clevert Journal: Medicina (Kaunas) Date: 2021-01-09 Impact factor: 2.430