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

Phase 4

Completed

• Conditions: Transplantation, Kidney
• Interventions: Drug: Optison; Diagnostic Test: Ultrasound (US); Diagnostic Test: Contrast-enhanced ultrasound (CEUS)

• Registration Number: NCT02625428
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-09
• Primary Completion: 2018-12
• Study Completion: 2019-12
• Status Verified: 2020-02
• Results First Submitted: 2020-02-15
• Results First Submitted QC: 2020-02-15
• Last Update Submitted: 2020-02-15
• Results First Posted: 2020-03-02
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
For Cause	Optison	For cause biopsies to evaluate a recent rise in serum creatinine.
For Cause	Contrast-enhanced ultrasound (CEUS)	For cause biopsies to evaluate a recent rise in serum creatinine.
Surveillance	Ultrasound (US)	Surveillance biopsies done after transplant mostly looking for subclinical rejection.
Surveillance	Contrast-enhanced ultrasound (CEUS)	Surveillance biopsies done after transplant mostly looking for subclinical rejection.
For Cause	Ultrasound (US)	For cause biopsies to evaluate a recent rise in serum creatinine.
Surveillance	Optison	Surveillance biopsies done after transplant mostly looking for subclinical rejection.

Primary Outcome Measures

Name	Time	Method
Abnormal Biopsy	1 year	Number of subjects with abnormal biopsies in either the primary or secondary biopsy location, by diagnosis from a clinical pathologist

Secondary Outcome Measures

Name	Time	Method
Number of Patients With a Higher Degree of Renal Transplant Rejection Using Multiple Biopsies Compared to a Single Biopsy.	1 year

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States