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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Vesico-Ureteral Reflux
Intervention Drug: OPTISON
Enrollment 31
Recruitment Details From September 2014 to April 2015, the study team recruited and enrolled 31 eligible subjects scheduled for the clinically indicated voiding cysteourethrography (VCUG) examination from the daily inpatients/outpatients program of the Radiology Department at the Children’s Hospital of Philadelphia.
Pre-assignment Details One subject was enrolled into the study (informed consent signed), however, sedation was required as standard of care to perform the clinically indicated VCUG examination. Sedation constitutes an exclusion criterion. Therefore, this subject although enrolled into the study, did not actually complete it.
Arm/Group Title ceVUS With the Use of OPTISON & VCUG in the Same Session
Hide Arm/Group Description

OPTISON will be resuspended just before the performance of ceVUS examination, and 0.1%-0.5% of the bladder filling volume OPTISON / normal saline solution will be used for intravesical administration. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with the maximum OPTISON dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children.

VCUG exam will be performed using the same bladder catheter with intravesical administration of the x-ray contrast agent.

Period Title: Overall Study
Started 31
Completed 30
Not Completed 1
Reason Not Completed
Protocol Violation             1
Arm/Group Title ceVUS With the Use of OPTISON & VCUG in the Same Session
Hide Arm/Group Description OPTISON will be resuspended just before the performance of ceVUS examination, and 01%-0.5% OPTISON solution will be used for intravesical administration. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with a maximum dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children. VCUG exam will be performed as part of the standard care using the same bladder catheter with intravesical administration of the x-ray contrast agent.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
30
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
21
  70.0%
Male
9
  30.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Hispanic or Latino
3
  10.0%
Not Hispanic or Latino
27
  90.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  16.7%
White
17
  56.7%
More than one race
6
  20.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
 100.0%
1.Primary Outcome
Title Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG).
Hide Description
  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.
Time Frame 10-15 minutes.
Hide Outcome Measure Data
Hide Analysis Population Description
In total, 59 kidneys with 62 pelvic-ureteric units (PUUs) in 30 children were analyzed.
Arm/Group Title Severity of Reflux With ceVUS Severity of Reflux With VCUG
Hide Arm/Group Description:
Contrast enhanced Voiding Urosonography (ceVUS) OPTISON will be performed with the intravesical administration of 0.1%-0.5% OPTISON/normal saline solution. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with a maximum dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children.
Voiding Cystourethrography (VCUG) exam will be performed after ceVUS using the same bladder catheter with intravesical administration of the x-ray contrast agent.
Overall Number of Participants Analyzed 30 30
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Pelvic-Ureteric-Units (PUUs)
62 62
Measure Type: Number
Unit of Measure: pelvic-ureteric units (PUUs)
Grade 0 reflux 50 50
Grade I reflux 2 2
Grade II reflux 8 6
Grade III reflux 2 4
Grade IV reflux 0 0
Grade V reflux 0 0
2.Primary Outcome
Title Number of Participants With Adverse Events Following Contrast Enhanced Voiding Urosonography (ceVUS) With OPTISON and Voiding Cystourethrography (VCUG).
Hide Description

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.

Time Frame Within 1 hour and up to 2 days after ceVUS and VCUG examinations completion.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ceVUS With the Use of OPTISON & VCUG in the Same Session
Hide Arm/Group Description:
OPTISON will be resuspended just before the performance of ceVUS examination, 0.1%-0.5% OPTISON solution will be used for intravesical administration. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with the maximum dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children. VCUG exam will be performed as part of the standard care using the same bladder catheter with intravesical administration of the x-ray contrast agent.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
Number of Participants without Adverse Events 29
Number of Participants with Adverse Events 1
3.Secondary Outcome
Title Compare the Diagnostic Accuracy of Contrast Enhanced Voiding Urosonography (ceVUS) With Voiding CystoUrethroGraphy (VCUG) for Vesicoureteral Reflux Detection and Urethral Imaging in Children.
Hide Description 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.
Time Frame 10-15 minutes.
Hide Outcome Measure Data
Hide Analysis Population Description
Voiding Cysteourethrography (VCUG) is used as the reference standard the results for ceVUS.
Arm/Group Title ceVUS With the Use of OPTISON & VCUG in the Same Session
Hide Arm/Group Description:
OPTISON will be resuspended just before the performance of ceVUS examination, and 0.1%-0.5% OPTISON solution will be used for intravesical administration. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with het maximum dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children. VCUG exam as part of the standard care will be performed using the same bladder catheter with intravesical administration of the x-ray contrast agent.
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
sensitivity
91.7
(61.5 to 99.8)
specificity
98.0
(89.4 to 99.9)
positive predictive value
91.7
(61.1 to 98.7)
negative predictive value
98.0
(88.2 to 99.7)
Time Frame During 48 hours following the study participation
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ceVUS With the Use of OPTISON & VCUG in the Same Session
Hide Arm/Group Description

OPTISON will be resuspended just before the performance of ceVUS examination, and 0.1%-0.5% of the bladder filling volume OPTISON / normal saline solution will be used for intravesical administration. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with the maximum OPTISON dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children.

VCUG exam will be performed using the same bladder catheter with intravesical administration of the x-ray contrast agent.

All-Cause Mortality
ceVUS With the Use of OPTISON & VCUG in the Same Session
Affected / at Risk (%)
Total   0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
ceVUS With the Use of OPTISON & VCUG in the Same Session
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ceVUS With the Use of OPTISON & VCUG in the Same Session
Affected / at Risk (%) # Events
Total   1/30 (3.33%)    
Renal and urinary disorders   
Dysuria  1 [1]  1/30 (3.33%)  1
1
Term from vocabulary, WHO
Indicates events were collected by systematic assessment
[1]
The dysuria was an anticipated adverse event and it was categorized as mild in severity, subacute in onset and self-limited in course. No medical consultation, no medication or other intervention was required or performed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kassa Darge, MD, PhD, Radiologist-in-Chief
Organization: Children’s Hospital of Philadelphia
Phone: 267-425-7110
EMail: DARGE@email.chop.edu
Layout table for additonal information
Responsible Party: Kassa Darge, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02204917     History of Changes
Other Study ID Numbers: IRB 13-010618
First Submitted: June 25, 2014
First Posted: July 31, 2014
Results First Submitted: July 19, 2017
Results First Posted: November 27, 2018
Last Update Posted: November 27, 2018