IRB 14-009240, Does CEUS Positively Influence Selection of Biopsy Sites When Evaluating Transplant Kidneys?

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-12-31

Brief Summary

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This is a pilot study to investigate whether contrast-enhanced ultrasound (CEUS) may help evaluate segmental differences in renal perfusion better than Doppler Ultrasound and thus help direct the biopsy to the most abnormal part of the renal cortex. This should maximize detection and increase the odds of demonstrating the true grade/severity of the histopathological abnormality.

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Detailed Description

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Conditions

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Transplantation, Kidney

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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For Cause

For cause biopsies to evaluate a recent rise in serum creatinine.

Group Type EXPERIMENTAL

Optison

Intervention Type DRUG

Ultrasound (US)

Intervention Type DIAGNOSTIC_TEST

A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.

Contrast-enhanced ultrasound (CEUS)

Intervention Type DIAGNOSTIC_TEST

Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.

Surveillance

Surveillance biopsies done after transplant mostly looking for subclinical rejection.

Group Type EXPERIMENTAL

Optison

Intervention Type DRUG

Ultrasound (US)

Intervention Type DIAGNOSTIC_TEST

A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.

Contrast-enhanced ultrasound (CEUS)

Intervention Type DIAGNOSTIC_TEST

Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.

Interventions

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Optison

Intervention Type DRUG

Ultrasound (US)

A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.

Intervention Type DIAGNOSTIC_TEST

Contrast-enhanced ultrasound (CEUS)

Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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ultrasound contrast agent

Eligibility Criteria

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Inclusion Criteria

* Ability to provide informed consent
* Male and female \>18 years
* Patients undergoing renal transplant ultrasound-guided percutaneous biopsy within 24 months post transplant including patients undergoing biopsy to evaluate a recent rise in serum creatinine so called for cause biopsies and patients undergoing routine protocol (surveillance) biopsies without other evident of renal dysfunction

Exclusion:

* Pregnant women or women who are nursing an infant are not able to participate in this study
* Known patent forearm ovale (PFO)
* Significant heart disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No