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

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ClinicalTrials.gov Identifier: NCT02204917
Recruitment Status : Completed
First Posted : July 31, 2014
Results First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Kassa Darge, Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE June 25, 2014
First Posted Date  ICMJE July 31, 2014
Results First Submitted Date  ICMJE July 19, 2017
Results First Posted Date  ICMJE November 27, 2018
Last Update Posted Date November 27, 2018
Study Start Date  ICMJE July 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
  • 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. ]
    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.
  • 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:
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
  • Evaluation ceVUS diagnostic feasibility. [ Time Frame: 10-15 minutes. ]
    The diagnostic feasibility of ceVUS will be assessed with respect to the following outcome measurements:
    1. Detection of reflux (presence of reflux or not).
    2. Grading of reflux (grades I-V).
    3. Urethra imaging and urethra pathology detection.
  • Evaluation of ceVUS safety with intravesical administration of OPTISON. [ Time Frame: Within 1 hour and up to 2 days after ceVUS and VCUG (Voiding CystoUrethroGraphy) examinations completion. ]
    The overall safety and tolerability of ceVUS with OPTISON will be assessed regarding the incidence, frequency, type, severity, onset and duration of potential adverse events as well as the body organ/system involved, based on the following evaluations:
    1. Physical examination: assessment of subject's overall physical condition and general appearance of skin and mucosal tissues in the perineal area.
    2. Vital signs: pulse rate and arterial oxygen saturation measurements.
    3. Adverse events evaluation: clinical signs of generalized hypersensitivity, allergic or anaphylactoid reactions.
    4. Follow-up phase: Telephone contact and questionnaire-based interview 48 hours after ceVUS examination for follow-up of any possible adverse events.
Change History Complete list of historical versions of study NCT02204917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
Compare the diagnostic accuracy of 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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)
Primary Purpose: Diagnostic
Condition  ICMJE Vesico-Ureteral Reflux
Intervention  ICMJE Drug: OPTISON
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
Study Arms  ICMJE 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.
Intervention: Drug: OPTISON
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2018)
31
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2014)
35
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02204917
Other Study ID Numbers  ICMJE IRB 13-010618
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kassa Darge, Children's Hospital of Philadelphia
Study Sponsor  ICMJE Kassa Darge
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kassa Darge, MD, PhD Department of Radiology, the Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP