Clinical trial NCT02204917: CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Vesico-Ureteral Reflux
Keywords: Ultrasound
Ultrasound Contrast Agents
Optison
contrast enhanced Voiding Urosonography (ceVUS)
ceVUS
Vesicoureteral Reflux
Children
Kidney
Bladder
Urethra
Voiding Cystourethrography (VCUG)
VCUG
Safety
Urinary tract
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 31
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Comparative performance of contrast enhanced Voiding Urosonography (ceVUS) and Voiding Cystourethrography (VCUG) in the same participant and in the same session.
Primary purpose: DIAGNOSTIC

Brief summary: In this clinical trial the investigators aim to evaluate the diagnostic feasibility and safety of ceVUS with the intravesical use of OPTISON for vesicoureteral reflux detection and urethral imaging in children.

Detailed description: Contrast enhanced Voiding Urosonography (ceVUS) is a radiation free, highly sensitive imaging modality for vesicoureteral reflux (VUR) and urethral imaging in children. It employs ultrasound technology in combination with ultrasound contrast agent, which is administered intravesically via a bladder catheter. Currently, second generation ultrasound contrast agents are commercially available, comprising of gas-filled microbubbles. CeVUS in children is being widely practiced, primarily in Europe, despite the fact that none of the commercially available ultrasound contrast agents are yet approved for clinical applications in pediatric population. In the United States, there is limited clinical experience with ceVUS in children. Among the currently commercially available ultrasound contrast agents, OPTISON has already been used in research and off-label in clinical settings involving adults and children. One in-vitro study has been conducted aiming to optimize the ultrasound technical parameters and the dose of OPTISON for intravesical administration in children. In this clinical trial the investigators aim to evaluate the diagnostic feasibility and safety of ceVUS with the intravesical use of OPTISON for vesicoureteral reflux detection and urethral imaging in children.

Eligibility criteria: Inclusion criteria:

1. Children 2-18 years (first age cohort).
2. Children 0-18 years (second age cohort).
3. Referred to the Children's Hospital of Philadelphia (CHOP) for the performance of the clinically indicated Voiding Cystourethrography (VCUG) examination.
4. Parental/guardian permission (informed consent) and if appropriate, child's assent for additional performance of contrast enhanced Voiding Urosonography (ceVUS) examination.

Exclusion criteria:

1. Hypersensitivity to perflutren, blood, blood products or albumin.
2. Children requiring sedation for VCUG or ceVUS examinations.
3. Parents/guardians or subjects who, in the opinion of the principal investigator, may be non-compliant with study schedules or procedures.

Primary outcomes:
measure: Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG).
timeFrame: 10-15 minutes.
measure: Number of Participants With Adverse Events Following Contrast Enhanced Voiding Urosonography (ceVUS) With OPTISON and Voiding Cystourethrography (VCUG).
timeFrame: Within 1 hour and up to 2 days after ceVUS and VCUG examinations completion.
Secondary outcomes:
measure: Compare the Diagnostic Accuracy of Contrast Enhanced Voiding Urosonography (ceVUS) With Voiding CystoUrethroGraphy (VCUG) for Vesicoureteral Reflux Detection and Urethral Imaging in Children.
timeFrame: 10-15 minutes.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Department of Radiology, the Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Department of Radiology, the Children's Hospital of Philadelphia
name: Kassa Darge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: