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contrast enhanced ultrasonography for Kidney Transplant Rejection

Phase 2
Waitlist Available
Led By Reza Abdi, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of study, an average of 2 years
Awards & highlights

Study Summary

This trial will test whether using a special ultrasound contrast agent can help doctors detect kidney transplant rejection earlier than with standard ultrasound.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of study, an average of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of study, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Indication of acute renal allograft rejection that has been confirmed by biopsy
Secondary outcome measures
Indication of chronic renal allograft rejection (CAN) that has been confirmed by biopsy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sonazoid contrastExperimental Treatment2 Interventions
The contrast agent Sonazoid will be used during contrast enhanced ultrasonography. This will be a one-time administration of the contrast agent. The contrast agent, Sonazoid (GE Healthcare), is a lipid-stabilized suspension of perfluorobutane microbubbles with a median diameter of 2.4-3.5 μm and will be administered per package insert (intravenously as a continuous infusion). Sonazoid contrast agent will be given at a dose 0.0075 mL/Kg as a bolus intravenous injection while visualizing the kidney transplant.
Group II: Medical ReviewActive Control1 Intervention
Ultrasound imaging will be taken from a group of subjects recruited for stage 2. These will be obtained through medical record review from subjects with successful renal transplant at BWH and no transplant rejection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perflubutane
FDA approved
contrast enhanced ultrasonography
2018
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

GE HealthcareIndustry Sponsor
289 Previous Clinical Trials
631,048 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,609 Previous Clinical Trials
11,470,319 Total Patients Enrolled
Reza Abdi, MDPrincipal InvestigatorBrigham and Women's Hospital

Frequently Asked Questions

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

Can you detail the outcomes of prior experiments involving contrast enhanced ultrasonography?

"Presently, there are 3 clinical trials researching the efficacy of contrast enhanced ultrasonography. Of these studies, none have reached Phase 3. While Philadelphia is a major research hub for this treatment, other sites in Pennsylvania are also running experiments on it."

Answered by AI

Does the FDA recognize contrast enhanced ultrasonography as a legitimate diagnostic tool?

"The safety of contrast enhanced ultrasonography was assessed as a 2, given the nature of this Phase 2 trial and its lack of evidence for efficacy."

Answered by AI

How many individuals have enrolled for participation in this experiment?

"Affirmative. The clinicaltrials.gov page indicates that this experiment is still in search of patients, having been created on May 30th 2018 and last updated on the 18th of May 2021. It needs to recruit a total of 30 participants from 1 medical centre."

Answered by AI

Does this experiment represent a fresh approach to treatment?

"At the present, this technology is being tested in three separate clinical trials across two cities and one country. The initial trial for contrast enhanced ultrasonography was conducted by GE Healthcare back in 2018, with thirty patients participating through Phase 2 drug approval. 8 research experiments have concluded since then."

Answered by AI

What criteria must participants meet to join this clinical experiment?

"This clinical trial is recruiting 30 individuals between 18 and 75 with a history of kidney transplant at Brigham and Women's Hospital. To qualify, participants must display signs of acute or chronic renal allograft rejection as determined by the examination of histological sections from biopsies performed on said organ recipients. Additionally, stage 2 applicants are required to present normal serum creatinine values (~1 mg/dl) through medical record review."

Answered by AI

Does this clinical research involve adult participants aged 55 and up?

"This research project is restricted to those aged 18-75. Additionally, there are 36 subgroups for minors and elderly participants respectively."

Answered by AI

Are any spots available for participants in this experiment yet?

"Data from clinicaltrials.gov reveals that this medical trial opened on May 30th 2018 and was recently updated in 18th of May 2021, indicating it is actively recruiting patients."

Answered by AI
Recent research and studies
~1 spots leftby Apr 2025