CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children (ceVUS)
|ClinicalTrials.gov Identifier: NCT02204917|
Recruitment Status : Completed
First Posted : July 31, 2014
Results First Posted : November 27, 2018
Last Update Posted : November 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vesico-Ureteral Reflux||Drug: OPTISON||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Comparative performance of contrast enhanced Voiding Urosonography (ceVUS) and Voiding Cystourethrography (VCUG) in the same participant and in the same session.|
|Masking:||None (Open Label)|
|Official Title:||Contrast Enhanced Voiding Urosonography (ceVUS) With the Intravesical Administration of the Ultrasound Contrast Agent OPTISON TM (Trademark) for Vesicoureteral Reflux Detection and Urethral Imaging in Children.|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2017|
Experimental: Comparative performance of ceVUS & VCUG
Contrast enhanced Voiding Urosonography (ceVUS) will be performed with the intravesical administration of 0.1%-0.5% OPTISON / normal saline solution. The exact OPTISON dose (ml) that will be adjusted according to the age-related bladder filling capacity with a dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children. Voiding Cystourethrography (VCUG) exam will be subsequently performed using the same bladder catheter with intravesical administration of the x-ray contrast agent.
Contrast enhanced Voiding Urosonography (ceVUS) with intravesical administration of OPTISON for vesicoureteral reflux detection and urethral imaging in children. Voiding Cystourethrography (VCUG) examination will be subsequently performed as part of the standard care.
Other Name: Perflutren Protein-Type A Microspheres
- Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). [ Time Frame: 10-15 minutes. ]
- Presence or absence of vesicoureteral reflux identified by ceVUS and VCUG in each pelvic-ureter-unit (PUU) of each participant. PUU is an anatomic term that is used to describe the part of the urinary tract consisting of the renal calyces, pelvis and ureter.
- Grading the severity of reflux detected by ceVUS and VCUG. Grade 0: absence of reflux. If reflux is present, a 5 grade scale (grades I-V) is used to evaluate its severity. Grade I: reflux in the ureter, grade II: reflux up to the renal pelvis, grade III: reflux up to the renal pelvis with mild dilation of the ureter and pelvicalyceal system, grade IV reflux up to the renal pelvis with moderate dilation but preserved papillary impressions, grade V: reflux up to the renal pelvis with severe dilation and loss of papillary impressions. Higher grades of reflux are associated with increased risk of urinary tract infection.
- Imaging of the urethra during voiding (urethra visualized or not) and urethra pathology detection.
- Number of Participants With Adverse Events Following Contrast Enhanced Voiding Urosonography (ceVUS) With OPTISON and Voiding Cystourethrography (VCUG). [ Time Frame: Within 1 hour and up to 2 days after ceVUS and VCUG examinations completion. ]
The overall safety and tolerability of ceVUS with OPTISON was assessed before, during and immediately after each ceVUS and VCUG examinations, and in follow-up telephone interviews. Assessments included:
- evaluation of body systems for signs of generalized hypersensitivity, allergic or anaphylactoid reactions
- monitoring of heart rate and pulse oxygen saturation
- telephone questionnaire-based interview of parents/guardians and children 48 hours after the examinations for delayed adverse events.
The severity of any possible adverse event was classified as mild, moderate or serious and the onset of symptoms was categorized as acute, subacute or delayed according to the World Health Organization (WHO) classifications. In addition, the adverse event was classified as anticipated if it was expected given the study related procedures or unanticipated if the subject was exposed to greater risk than previously known or recognized.
- Compare the Diagnostic Accuracy of Contrast Enhanced Voiding Urosonography (ceVUS) With Voiding CystoUrethroGraphy (VCUG) for Vesicoureteral Reflux Detection and Urethral Imaging in Children. [ Time Frame: 10-15 minutes. ]The diagnostic accuracy of ceVUS will be assessed by evaluation of the true positive, true negative, false positive and false negative cases of reflux and urethral imaging findings detected by ceVUS and VCUG examinations.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204917
|United States, Pennsylvania|
|Department of Radiology, the Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Kassa Darge, MD, PhD||Department of Radiology, the Children's Hospital of Philadelphia|