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Completed

NCT Number: NCT02733029

Contrast Enhanced Ultrasonography to Detect Human Renal Transplant Rejection

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

This study will be divided into two stages. In the first stage the investigators will assess the transplant kidney with ultrasound after contrast injection (Sonazoid) to determine if contrast in the kidney is detectable by ultrasound and to determine if the amount of perfusion can be quantified directly or qualitatively. The investigators aim to have one to two subjects in this stage. If perfusion of the kidney can be assessed, then the investigators will move to stage two of the study.

In stage 2, the investigators will look to determine the ability of the contrast enhanced ultrasonography method to detect renal transplant rejection using Sonazoid. For this stage the investigators will recruit subjects with biopsy confirmed renal transplant rejection. Once subjects are consented, they will undergo contrast enhanced ultrasonography with Sonazoid and have images taken. These images will be compared to images of renal transplant patients that have displayed no rejection or clinical issues. These clinically normal subjects will have previously consented to a medical record review so that the investigators may use their images.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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]

Exclusion criteria

  • 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

Treatment and study plan

Sonazoid

Drug

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

contrast enhanced ultrasonography

Device

Injection of intravenous ultrasound contrast

Primary outcomes

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

    Time frame: 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

    Time frame: Through completion of study, an average of 2 years

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • GE Healthcare

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Apr 11, 2016
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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