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NCT02911714 · ClinicalTrials.gov registry record · Phase 1
Contrast-Enhanced Ultrasound for Kidney Transplant
A Phase 1 study, sponsored by University of Utah.
- Terminated
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02911714: Clinical Trial Phase 1 study, sponsored by University of Utah.
NCT02911714 is a Phase 1 study that was terminated before completion, run by University of Utah. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02911714, a Phase 1 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Contrast-enhanced ultrasound (CEUS) is a promising non-invasive imaging tool that may aid in the early detection of kidney transplant complications, such as delayed graft function (DGF) and acute allograft rejection. The technique uses an intravenous contrast agent to improve organ visualization with standard duplex ultrasound equipment. A number of FDA-approved agents, including Optison, Definity and Lumason are widely used to improve visualization in technically limited echocardiograms, and Lumason was recently approved for contrast-enhanced ultrasound of the liver. The specific aims of this study are to: develop, implement and refine a contrast-enhanced ultrasound protocol using Lumason to safely maximize kidney allograft visualization; determine associations between contrast-enhanced ultrasound and patterns of allograft injury consistent with delayed graft function; and to compare contrast-enhanced ultrasound with duplex ultrasound for differentiating acute rejection from other causes of dysfunction.
Primary Outcome
A meta-analysis of 19 studies found urine neutrophil gelatinase-associated lipocalin (NGAL) \>150 ng/mL (within hours of the inciting event) had an area under the receiver-operating characteristic curve (AUC) of 0.815 for identifying acute kidney injury (defined as an ensuing rise in serum creatinine by ≥50%). We noted an AUC of 0.82 for predicting the need for dialysis in the first week (i.e., dialysis-defined delayed graft function) with an optimal urine NGAL cutoff of \>350 ng/mL. For this st
Interventions
- DRUG Lumason Contrast-Enhanced Ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-02-21 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 1 |
Why NCT02911714 stopped before completion
NCT02911714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Lumason Contrast-Enhanced Ultrasound is the first listed.
NCT02911714 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02911714 about?
NCT02911714 is a clinical study titled "Contrast-Enhanced Ultrasound for Kidney Transplant". Contrast-enhanced ultrasound (CEUS) is a promising non-invasive imaging tool that may aid in the early detection of kidney transplant complications, such as delayed graft function (DGF) and acute allograft rejection. The technique uses an intravenous contrast agent to improve organ visualization wit...
What is the current status of trial NCT02911714?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2018-02-21. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT02911714?
The interventions under investigation include: Lumason Contrast-Enhanced Ultrasound (DRUG).
Who is sponsoring clinical trial NCT02911714?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02911714's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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