Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02986477
Recruitment Status : Withdrawn (PI leaving institution)
First Posted : December 8, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE December 5, 2016
First Posted Date  ICMJE December 8, 2016
Last Update Posted Date January 25, 2018
Actual Study Start Date  ICMJE January 1, 2017
Actual Primary Completion Date January 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration [ Time Frame: 10 years ]
The presence of vesicoureteral reflux is assessed as the primary outcome measure. Qualitative evaluation is performed to assess the presence of contrast within the collecting systems, which then correlates with vesicoureteral reflux. Since this is a qualitative evaluation based on the acquired radiologic images, there is no unit, but the degree of vesicoureteral reflux is assessed. Vesicoureteral reflux is graded into I to V grades based on the severity.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02986477 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration
Official Title  ICMJE Clinical Applications of Contrast-Enhanced Ultrasonography in Pediatric Population - Intravesicle Administration
Brief Summary In children, specifically the intravesicle administration to study vesicoureteral reflux in children already catheterized and scheduled for voiding cystourethrogram (VCUG). Contrast-enhanced ultrasonography is a tremendous advancement from conventional B-mode and color Doppler ultrasonography, as it permits noninvasive, non-ionizing delineation of physiology and pathophysiology with higher resolution and accuracy in children. The technique is particularly useful in pediatric population whose lifetime risk of cancer significantly increases with higher frequency of ionizing radiation. Voiding cystourethrogram is a fluoroscopy technique that can study reflux real time but at the risk of radiation side effects. In this regard, intravesicle administration of ultrasound contrast agent can help avoid radiation in children and potentially replace the conventionally used voiding cystourethrogram.
Detailed Description

The most commonly used genitourinary application of ultrasound contrast agent is for the diagnosis of vesicoureteral reflux via intra-vesicle administration of contrast agent. The utility of ultrasound contrast agent in contrast-enhanced voiding urosonography is well established and published over two decades (Darge 2002, Darge 2008, Darge 2010). As with other applications of ultrasound contrast agents, the method offers the advantages of no radiation, low cost, excellent anatomic detail, and higher sensitivity for reflux detection than VCUG. The most comprehensive study to detail the safety profile of intravesicle ultrasound contrast is by Papadopoulou et al. (Papadopoulou, Ntoulia et al. 2014) which described a total of 1,010 children (563 girls, 447 boys) with a mean age of 2.9 years. No adverse events were reported at 1 hour after exam. Follow-up phone interviews revealed no adverse events in the majority (973 of 1,010). The remaining 37 children experienced mild symptoms including dysuria (n=26) and urinary retention (n=2) which may have been related to catheterization rather than the contrast agent. A recent European survey at 29 centers evaluating the use of ultrasound contrast agent in 4,131 children for pediatric reflux diagnosis reported no adverse events (Riccabona 2012).

The procedure consists of pre-contrast, post-contrast, voiding phase, and post-void depiction of the kidneys, ureters, bladder, and transperineal scan of the urethra, for identification of potential ectopic ureters (Darge 2008, Duran, del Riego et al. 2012) that can easily be missed on non-distended ureters on CT, MRI, or radionuclide imaging. The two primary methods of contrast injection includes direct injection into a partially filled bladder (Darge 2008) and another using a saline bag for subsequent drip infusion via the catheter into the bladder (Back, Edgar et al. 2015).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Vesico-Ureteral Reflux
Intervention  ICMJE Other: Contrast Ultrasound
For diagnostic purposes, intravesicle administration of contrast ultrasound agent will be performed to study vesicoureteral reflux.
Study Arms  ICMJE Contrast Ultrasound
Patients with vesicoureteral reflux will receive contrast ultrasound via Foley catheter for study of vesicoureteral reflux.
Intervention: Other: Contrast Ultrasound
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 22, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2016)
2000
Actual Study Completion Date  ICMJE January 9, 2018
Actual Primary Completion Date January 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients aged 0-17 years undergoing an ultrasound for a clinical indication at the Johns Hopkins Hospital
  • Willing to either extend a previously scheduled clinically indicated voiding cystourethrogram

Exclusion Criteria:

  • Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
  • History of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in LUMASON. Inactive ingredients include 1,2-Dipalmitoyl-sn-glycero-3-phosphoglycerol, sodium salt (DPPG), a minor (1-2%) component normally present in most cell membranes, Diasteroylphosphatidylcholine (DSPC), a commonly used synthetic phospholipids, and palmitic acid, the most commonly found fatty acid in animals.
  • Patient subjects in unstable clinical condition.
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02986477
Other Study ID Numbers  ICMJE 00118038
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Johns Hopkins University
Verification Date January 2018

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