TerminatedPhase 1

Contrast-Enhanced Ultrasound for Kidney Transplant

Stopped: lack of funding

United States20 participantsStarted 2018-02-21

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult living-donor or deceased-donor kidney transplant recipients Exclusion Criteria: * Subject is Pregnant * History of non-renal transplant * Uncontrolled diabetes or hypertension * Symptomatic or significant pulmonary or cardiovascular disease * Clinical decision by the treating team to forego the study procedure due to medical/surgical instability

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Biomarker-Defined Delayed Graft Function

Timeframe: Post-Operative Day 1

Biopsy-Proven Acute Rejection

Timeframe: Any Time After Kidney Transplantation

Trial details

NCT IDNCT02911714

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Kidney Transplantation trials