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Completed

NCT Number: NCT02786810

Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

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

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Key information

Conditions

Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Bladder Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases Vesico-Ureteral Reflux Vesicoureteral Reflux

Age range

8 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Tennessee Health Science Center

Memphis, Tennessee, 38013, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulfur hexafluoride type-a lipid microspheres

Drug

Used as a contrast to enhance renal ultrasound

Other names: Lumason®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2016
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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