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Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

StatusNot Yet Recruiting
PhasePhase 1
Started
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Record History

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  1. Primary completion date: Apr 2024 to Jun 2029
    • Start date: Oct 1, 2023 to Jul 1, 2027
    • Study completion date: Jun 2024 to Jul 2029
    • Interventions: Lumason (Drug) to Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] (Drug)
    v8
  2. Start date: Aug 22, 2019 to Oct 1, 2023
    • Trial status: Active, Not Recruiting to Not Yet Recruiting
    • Site contact updated
    v7
  3. Primary completion date: Apr 2022 to Apr 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 2022 to Jun 2024
    • Site details revised
    v6
  4. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Dec 2019 to Apr 2022
    • Study sites: 0 to 1
    • Study completion date: Jun 2020 to Jun 2022
    • Start date changed from estimate of Jun 24, 2019 to Aug 22, 2019
  5. Phase: Phase 4 to Phase 1v4 Show 5 more changesShow less
    • Primary completion date: Mar 2019 to Dec 2019
    • Start date: Nov 2018 to Jun 24, 2019
    • Enrollment target: 60 to 70
    • Study completion date: Jun 2019 to Jun 2020
    • Study title shortened, about 3 words
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Sep 2018 to Nov 2018
    • Eligibility criteria revised
    v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In this research study the investigators want to study a safe, radiation-free technique known as contrast-enhanced ultrasound that may improve the ability to diagnose or evaluate renal scarring compared to regular ultrasound. This technique requires injection into a vein of a small amount of contrast material called Lumason. Contrast material is a type of dye that helps the investigators image the structures in the body more clearly. If this technique is successful, the need for DMSA studies may be avoided to diagnose or evaluate kidney scarring. DMSA is a more expensive test, causes radiation exposure, may require sedation and/or injection of contrast agents with the potential to cause allergic reactions.
Trial Details
NCT Number NCT03653702
Lead Sponsor Boston Children's Hospital
Conditions
(from sponsor)		 Vesico-Ureteral Reflux
Related terms Vesico-Ureteral Reflux
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov