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

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Transplantation, Kidney

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02625428

14-009240

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

For Cause

Experimental group

Description:

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

Treatment:

Diagnostic Test: Contrast-enhanced ultrasound (CEUS)

Drug: Optison

Diagnostic Test: Ultrasound (US)

Surveillance

Experimental group

Description:

Surveillance biopsies done after transplant mostly looking for subclinical rejection.

Treatment:

Diagnostic Test: Contrast-enhanced ultrasound (CEUS)

Drug: Optison

Diagnostic Test: Ultrasound (US)