NCT02733029

Brief Summary

The purpose of this study is to determine the feasibility and efficacy of detecting kidney transplant rejection using contrast enhance ultrasonography with the contrast agent Sonazoid.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
2.1 years until next milestone

Study Start

First participant enrolled

May 30, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

March 18, 2016

Last Update Submit

March 2, 2023

Conditions

Renal Transplant Rejection

Outcome Measures

Primary Outcomes (1)

  • Indication of acute renal allograft rejection that has been confirmed by biopsy

    Through completion of study, an average of 2 years

Secondary Outcomes (1)

  • Indication of chronic renal allograft rejection (CAN) that has been confirmed by biopsy

    Through completion of study, an average of 2 years

Study Arms (2)

Sonazoid contrast

EXPERIMENTAL

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.

Drug: SonazoidDevice: contrast enhanced ultrasonography

Medical Review

NO 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.

Interventions

SonazoidDRUG

Sonazoid (GE Healthcare) is a contrast agent that is a lipid-stabilized suspension of perfluorobutane microbubbles

Sonazoid contrast
contrast enhanced ultrasonographyDEVICE

Injection of intravenous ultrasound contrast

Sonazoid contrast

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (ages 18-75) who have undergone renal transplant at the Brigham and Women's Hospital. \[For stage 1 or stage 2\]
  • Experiencing acute and chronic renal allograft rejection - defined by by examining the histological sections of renal transplant biopsy for a renal pathologist. This is the most accurate way to evaluate the presence of absence of acute and chronic renal transplant biopsy. \[For stage 2\]
  • Adults (ages 18-75) who have undergone renal transplant at the Brigham and Women's Hospital with normal serum creatinine values (\~1 mg/dl) \[For stage 2 medical record review only\]

You may not qualify if:

  • Hemodynamic instability (e.g., blood pressure \< 90)
  • Atrial fibrillation with rapid ventricular response
  • Arrhythmia
  • Poor acoustic windows
  • Inability to provide informed consent
  • Known right to left or bidirectional cardiac shunts
  • Any contraindication such as the history of allergic reactions
  • Pregnant or nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • Jeetley P, Hickman M, Kamp O, Lang RM, Thomas JD, Vannan MA, Vanoverschelde JL, van der Wouw PA, Senior R. Myocardial contrast echocardiography for the detection of coronary artery stenosis: a prospective multicenter study in comparison with single-photon emission computed tomography. J Am Coll Cardiol. 2006 Jan 3;47(1):141-5. doi: 10.1016/j.jacc.2005.08.054. Epub 2005 Dec 15.

    PMID: 16386678BACKGROUND

  • Tsuruoka K, Yasuda T, Koitabashi K, Yazawa M, Shimazaki M, Sakurada T, Shirai S, Shibagaki Y, Kimura K, Tsujimoto F. Evaluation of renal microcirculation by contrast-enhanced ultrasound with Sonazoid as a contrast agent. Int Heart J. 2010 May;51(3):176-82. doi: 10.1536/ihj.51.176.

    PMID: 20558907BACKGROUND

  • Siedlecki AM, Benson C, Frates M, Azzi J, Hoffman RJ, Milford E, Weins A, Chandraker A, Mc Donald N, Philip White J, Abdi R. First Report of Perfluorobutane Microsphere-Enhanced Ultrasound in the Transplant Kidney. Transplantation. 2019 Oct;103(10):e283-e284. doi: 10.1097/TP.0000000000002856. No abstract available.

    PMID: 31335773DERIVED

MeSH Terms

Interventions

Sonazoid

Study Officials

  • Reza Abdi, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Transplant Nephrologist

Study Record Dates

First Submitted

March 18, 2016

First Posted

April 11, 2016

Study Start

May 30, 2018

Primary Completion

May 30, 2022

Study Completion

February 1, 2023

Last Updated

March 6, 2023

Record last verified: 2023-03

Locations

US(1)