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Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

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. Identifier: NCT02786810
Recruitment Status : Completed
First Posted : June 1, 2016
Results First Posted : April 4, 2018
Last Update Posted : May 11, 2018
Information provided by (Responsible Party):
University of Tennessee

Brief Summary:
The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Vesicoureteral Reflux Drug: Sulfur hexafluoride type-a lipid microspheres Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
Study Start Date : March 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Ultrasound

Arm Intervention/treatment
All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary.
Drug: Sulfur hexafluoride type-a lipid microspheres
Used as a contrast to enhance renal ultrasound
Other Name: Lumason®

Primary Outcome Measures :
  1. Visualization of Renal Scars Compared to Previous Imaging [ Time Frame: 1 hour ]
    The study will evaluate the contrast agent's ability to enable the ultrasound to produce adequate images of the kidneys as compared to the subject's previous renal imaging. This outcome will be measured in percentage of scars visualized by other imaging methods that were detected by using the contrast agent.

Secondary Outcome Measures :
  1. Number of Participants With Adverse Events Related to the Study Drug. [ Time Frame: 1 week ]
    The study will evaluate how many people experience adverse events, specifically the two most common effects (headache and nausea), during the study or during the week following the study.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Informed consent
  • Age more than or equal to 8 years
  • Patient with history of urinary tract infection (UTI) and history of Voiding Cystourethrogram (VCUG) for vesicoureteral reflux
  • Candidate for Dimercaptosuccinic acid (DMSA) scan or scan for renal scar
  • Demonstration of renal scarring by DMSA scan or renal ultrasound without contrast

Includes healthy volunteers

Exclusion Criteria:

  • Age less than 8years
  • Allergy to contrast or related products
  • Cardiac shunt/ congenital heart anomalies
  • Abnormal baseline ECG
  • Open heart surgery
  • Evidence of retinopathy
  • Patient in intensive care
  • Unable to comply with study requirement
  • History of emphysema
  • Unable to maintain oxygen saturation of 92% on at room air
  • Pregnancy and lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02786810

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United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38013
Sponsors and Collaborators
University of Tennessee
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Principal Investigator: David Hains, M.D. University of Tennessee Health Science Center
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Responsible Party: University of Tennessee Identifier: NCT02786810    
Other Study ID Numbers: 1504311FB
First Posted: June 1, 2016    Key Record Dates
Results First Posted: April 4, 2018
Last Update Posted: May 11, 2018
Last Verified: May 2016
Additional relevant MeSH terms:
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Urinary Tract Infections
Gastroesophageal Reflux
Vesico-Ureteral Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urologic Diseases
Urinary Bladder Diseases