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Contrast-Enhanced Ultrasound for Kidney Transplant Complications

Q: Has there been precedent for the use of Lumason Contrast-Enhanced Ultrasound in prior clinical trials?

<p>Currently, two trials for Lumason Contrast-Enhanced Ultrasound are in Phase 3 and 14 total studies ongoing. With a concentration of sites located around Philadelphia, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a> there are 18 centres across the United States running these clinical trials.</p>

Phase 1

Recruiting

Led By Isaac E Hall, M.D.

Research Sponsored by Isaac E. Hall

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult living-donor or deceased-donor kidney transplant recipients

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first post-operative week

Awards & highlights

Study Summary

This trialtests if CEUS using contrast agents (Optison, Definity and Lumason) can detect kidney transplant complications, like delayed graft function and acute allograft rejection, earlier and more safely than duplex ultrasound.

Who is the study for?

This trial is for adults who have received a kidney transplant from either a living or deceased donor. It's not suitable for pregnant individuals, those with unstable medical/surgical conditions, previous non-renal transplants, uncontrolled diabetes or hypertension, or serious lung/heart disease.Check my eligibility

What is being tested?

The study tests Lumason Contrast-Enhanced Ultrasound (CEUS) to detect early complications in kidney transplants like delayed function and rejection. CEUS uses an IV contrast agent with ultrasound to better visualize the new kidney compared to standard methods.See study design

What are the potential side effects?

While generally safe and non-invasive, contrast agents used in CEUS can sometimes cause mild side effects such as nausea, headache, flushing or allergic reactions. Serious side effects are rare but may include heart problems or severe allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have received a kidney transplant from a living or deceased donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Biomarker-Defined Delayed Graft Function

Biopsy-Proven Acute Rejection

Secondary outcome measures

Dialysis-Defined Delayed Graft Function

Trial Design

2Treatment groups

Experimental Treatment

Group I: CEUS and Delayed Graft FunctionExperimental Treatment1 Intervention

On the first post-operative day after kidney transplantation, recipients enrolled in the study will undergo CEUS using Lumason to quantify microvascular perfusion within the cortical and medullary zones of the kidney allograft for comparison to the concentration of neutrophil gelatinase-associated lipocalin (NGAL, an early biomarker of acute kidney injury) measured from recipient urine simultaneously collected on the first post-operative day.

Group II: CEUS and Biopsy-Proven Acute RejectionExperimental Treatment1 Intervention

We will identify and enroll kidney transplant recipients in need of clinically-indicated duplex ultrasounds and possible biopsy to evaluate allograft dysfunction during hospital admissions and outpatient follow-up. Immediately after the duplex ultrasound, we will perform CEUS using Lumason for allograft perfusion measurements to determine its potential association with biopsy-proven acute rejection according to the most recent Banff criteria.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

National Kidney FoundationOTHER

28 Previous Clinical Trials

84,962 Total Patients Enrolled

Isaac E. HallLead Sponsor

American Heart AssociationOTHER

326 Previous Clinical Trials

4,933,571 Total Patients Enrolled

Media Library

Kidney Transplant Research Study Groups: CEUS and Biopsy-Proven Acute Rejection, CEUS and Delayed Graft Function

Kidney Transplant Clinical Trial 2023: Lumason Contrast-Enhanced Ultrasound Highlights & Side Effects. Trial Name: NCT02911714 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How has Lumason Contrast-Enhanced Ultrasound been proven to pose no negative health risks?

"Considering the limited clinical data available regarding Lumason Contrast-Enhanced Ultrasound, it was awarded a score of 1 for safety."

Answered by AI

How many individuals are being monitored as part of this research endeavor?

"Affirmative. Data from clinicaltrials.gov states that the trial, which was first publicized on February 21st 2018, is currently seeking volunteers for participation. 55 individuals need to be recruited across 1 site."

Answered by AI

Are individuals currently able to join this clinical experiment?

"Correct. According to clinicaltrials.gov, this scientific trial is recruiting participants at the moment; it was posted on February 21st 2018 and revised on October 3rd 2022. 55 people are being accepted from one medical facility."

Answered by AI

Is this the inaugural instance of such research?

"Since 2017, Lumason Contrast-Enhanced Ultrasound has been under clinical investigation. Bracco Diagnostics Inc sponsored the original trial in 2017 which involved 125 participants and brought about its Phase < 1 Drug approval. Currently there are 14 live trials taking place across 10 cities located in 3 different countries."

Answered by AI

Has there been precedent for the use of Lumason Contrast-Enhanced Ultrasound in prior clinical trials?

"Currently, two trials for Lumason Contrast-Enhanced Ultrasound are in Phase 3 and 14 total studies ongoing. With a concentration of sites located around Philadelphia, Pennsylvania there are 18 centres across the United States running these clinical trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Contrast-Enhanced Ultrasound for Kidney Transplant

Isaac E. Hall 2018. "Contrast-Enhanced Ultrasound for Kidney Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02911714.

All > Kidney Transplant