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

NCT02625428 | Completed Phase 4 Results FDA Device

• 1 other identifier: 14-009240
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplantation, Kidney

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Patients With a Higher Degree of Renal Transplant Rejection Using Multiple Biopsies Compared to a Single Biopsy.

  1 year

Study Arms (2)

For Cause

EXPERIMENTAL

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

Drug: Optison; Diagnostic Test: Ultrasound (US); Diagnostic Test: Contrast-enhanced ultrasound (CEUS)

Surveillance

EXPERIMENTAL

Surveillance biopsies done after transplant mostly looking for subclinical rejection.

Drug: Optison; Diagnostic Test: Ultrasound (US); Diagnostic Test: Contrast-enhanced ultrasound (CEUS)

Interventions

Optison DRUG

Also known as: ultrasound contrast agent

For Cause; Surveillance

Ultrasound (US) 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.

For Cause; Surveillance

Contrast-enhanced ultrasound (CEUS) 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.

For Cause; Surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

FS 069; Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: J. Scott Kriegshauser
• Organization: Mayo Clinic

skriegshauser@mayo.edu

480-342-5664

Study Officials

• J Kriegshauser, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: December 9, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: March 2, 2020
• Results First Posted: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)