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

Transplantation, Kidney Clinical Trial

Official title:

Does Contrast-Enhanced Ultrasound Positively Influence Selection of Biopsy Sites When Evaluating Transplant Kidneys?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625428
• Other study ID #: 14-009240
• Status: Completed
• Phase: Phase 4
• Start date: November 2015
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion

• 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

Related Conditions & MeSH terms

• Transplantation, Kidney

Intervention

Drug:
• Optison

Diagnostic Test:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal Biopsy	Number of subjects with abnormal biopsies in either the primary or secondary biopsy location, by diagnosis from a clinical pathologist	1 year
Secondary	Number of Patients With a Higher Degree of Renal Transplant Rejection Using Multiple Biopsies Compared to a Single Biopsy.		1 year

External Links

•   Mayo Clinic Clinical Trials