Contrast Enhanced Ultrasonography to Detect Human Renal Transplant Rejection

Renal Transplant Rejection Clinical Trial

Official title:

Contrast Enhanced Ultrasonography to Detect Human Renal Transplant Rejection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733029
• Other study ID #: 2016P000574
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Renal Transplant Rejection

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