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CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children

Information source: Children's Hospital of Philadelphia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vesico-Ureteral Reflux

Intervention: OPTISON (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Children's Hospital of Philadelphia

Official(s) and/or principal investigator(s):
Kassa Darge, MD, PhD, Principal Investigator, Affiliation: Department of Radiology, the Children's Hospital of Philadelphia

Overall contact:
Kassa Darge, MD, PhD, Phone: 267-425-7108, Email: darge@email.chop.edu

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.

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome:

Evaluation ceVUS diagnostic feasibility.

Evaluation of ceVUS safety with intravesical administration of OPTISON.

Secondary outcome: Compare the diagnostic accuracy of ceVUS with Voiding CystoUrethroGraphy (VCUG) 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

Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion criteria: 1. Children 2-18 years (first age cohort). 2. Children 0-18 years (second age cohort). 3. Referred to CHOP for the performance of the clinically indicated VCUG examination. 4. Parental/guardian permission (informed consent) and if appropriate, child's assent for additional performance of 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.

Locations and Contacts

Kassa Darge, MD, PhD, Phone: 267-425-7108, Email: darge@email.chop.edu

Department of Radiology, the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Kassa Darge, MD, PhD, Principal Investigator
Additional Information

Starting date: July 2014
Last updated: August 3, 2015

Page last updated: August 23, 2015

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