Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

NCT02786810 | Completed Phase 2 Results

• 1 other identifier: 1504311FB
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Tract Infection; Vesicoureteral Reflux

Outcome Measures

Primary Outcomes (1)

• Visualization of Renal Scars Compared to Previous Imaging

  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.

  1 hour

Secondary Outcomes (1)

• Number of Participants With Adverse Events Related to the Study Drug.

  1 week

Study Arms (1)

Contrast

OTHER

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

Interventions

Sulfur hexafluoride type-a lipid microspheres DRUG

Used as a contrast to enhance renal ultrasound

Also known as: Lumason®

Contrast

Eligibility Criteria

• Age: 8 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38013, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Vesico-Ureteral Reflux

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases

Results Point of Contact

• Title: Dr. David Hains
• Organization: University of Tennessee Health Science Center

dhains@uthsc.edu

9012874876

Study Officials

• David Hains, M.D.

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: June 1, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 11, 2018
• Results First Posted: April 4, 2018

Record last verified: 2016-05

Locations

US (1)