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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02733029
Other study ID # 2016P000574
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 30, 2018
Est. completion date February 1, 2023

Study information

Verified date March 2023
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date February 1, 2023
Est. primary completion date May 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sonazoid
Sonazoid (GE Healthcare) is a contrast agent that is a lipid-stabilized suspension of perfluorobutane microbubbles
Device:
contrast enhanced ultrasonography
Injection of intravenous ultrasound contrast

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital GE Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Indication of acute renal allograft rejection that has been confirmed by biopsy Through completion of study, an average of 2 years
Secondary Indication of chronic renal allograft rejection (CAN) that has been confirmed by biopsy Through completion of study, an average of 2 years
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