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

NCT02204917 | Completed Phase 1 Results DMC

• 1 other identifier: IRB 13-010618
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG).

  1. 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. 2. 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. 3. Imaging of the urethra during voiding (urethra visualized or not) and urethra pathology detection.

  10-15 minutes.

• Number of Participants With Adverse Events Following Contrast Enhanced Voiding Urosonography (ceVUS) With OPTISON and Voiding Cystourethrography (VCUG).

  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: 1. evaluation of body systems for signs of generalized hypersensitivity, allergic or anaphylactoid reactions 2. monitoring of heart rate and pulse oxygen saturation 3. 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.

  Within 1 hour and up to 2 days after ceVUS and VCUG examinations completion.

Secondary Outcomes (1)

• Compare the Diagnostic Accuracy of Contrast Enhanced Voiding Urosonography (ceVUS) With Voiding CystoUrethroGraphy (VCUG) for Vesicoureteral Reflux Detection and Urethral Imaging in Children.

  10-15 minutes.

Study Arms (1)

Comparative performance of ceVUS & VCUG

EXPERIMENTAL

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.

Drug: OPTISON

Interventions

OPTISON DRUG

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.

Also known as: Perflutren Protein-Type A Microspheres

Comparative performance of ceVUS & VCUG

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kassa Darge: lead

Study Sites (1)

Department of Radiology, the Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Vesico-Ureteral Reflux

Interventions

FS 069

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Kassa Darge, MD, PhD, Radiologist-in-Chief
• Organization: Children's Hospital of Philadelphia

DARGE@email.chop.edu

267-425-7110

Study Officials

• Kassa Darge, MD, PhD

  Department of Radiology, the Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Comparative performance of contrast enhanced Voiding Urosonography (ceVUS) and Voiding Cystourethrography (VCUG) in the same participant and in the same session.

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: July 31, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2017
• Last Updated: November 27, 2018
• Results First Posted: November 27, 2018

Record last verified: 2018-10

Locations

US (1)