CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children (ceVUS)
Vesico-Ureteral Reflux
About this trial
This is an interventional diagnostic trial for Vesico-Ureteral Reflux focused on measuring Ultrasound, Ultrasound Contrast Agents, Optison, contrast enhanced Voiding Urosonography (ceVUS), ceVUS, Vesicoureteral Reflux, Children, Kidney, Bladder, Urethra, Voiding Cystourethrography (VCUG), VCUG, Safety, Urinary tract
Eligibility Criteria
Inclusion criteria:
- Children 2-18 years (first age cohort).
- Children 0-18 years (second age cohort).
- Referred to the Children's Hospital of Philadelphia (CHOP) for the performance of the clinically indicated Voiding Cystourethrography (VCUG) examination.
- Parental/guardian permission (informed consent) and if appropriate, child's assent for additional performance of contrast enhanced Voiding Urosonography (ceVUS) examination.
Exclusion criteria:
- Hypersensitivity to perflutren, blood, blood products or albumin.
- Children requiring sedation for VCUG or ceVUS examinations.
- Parents/guardians or subjects who, in the opinion of the principal investigator, may be non-compliant with study schedules or procedures.
Sites / Locations
- Department of Radiology, the Children's Hospital of Philadelphia
Arms of the Study
Arm 1
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.