Phase 4
N=40
IRB 14-009240, Does CEUS Positively Influence Selection of Biopsy Sites When Evaluating Transplant Kidneys?
Transplantation, Kidney
Bottom Line
View on ClinicalTrials.gov: NCT02625428 ↗Enrolled (actual)
40
Serious AEs
7.5%
Results posted
Mar 2020
Primary outcome: Primary: Abnormal Biopsy — 10; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Optison (Drug); Ultrasound (US) (Diagnostic_test); Contrast-enhanced ultrasound (CEUS) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abnormal Biopsy |
10; 7 | — |
| SECONDARY Number of Patients With a Higher Degree of Renal Transplant Rejection Using Multiple Biopsies Compared to a Single Biopsy. |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02625428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.