Transplantation, Kidney
Conditions
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.
Interventions
DRUGOptison
DIAGNOSTIC_TESTUltrasound (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.
DIAGNOSTIC_TESTContrast-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.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of Patients With a Higher Degree of Renal Transplant Rejection Using Multiple Biopsies Compared to a Single Biopsy. | 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| For Cause For cause biopsy to evaluate a recent rise in serum creatinine.
Optison
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. | 20 |
| Surveillance Surveillance biopsy done after transplant mostly looking for subclinical rejection.
Optison
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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | For Cause | Surveillance | Total |
|---|---|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 13.4 | 50.8 years STANDARD_DEVIATION 14.1 | 52.6 years STANDARD_DEVIATION 13.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Serum Creatinine | 3.3 mg/dL STANDARD_DEVIATION 1.9 | 1.5 mg/dL STANDARD_DEVIATION 0.4 | 2.4 mg/dL STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 8 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 12 Participants | 16 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 2 / 20 | 1 / 20 |
Outcome results
Primary
Abnormal Biopsy
Number of subjects with abnormal biopsies in either the primary or secondary biopsy location, by diagnosis from a clinical pathologist
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| For Cause | Abnormal Biopsy | 10 Participants |
| Surveillance | Abnormal Biopsy | 7 Participants |
Secondary
Number of Patients With a Higher Degree of Renal Transplant Rejection Using Multiple Biopsies Compared to a Single Biopsy.
Time frame: 1 year
Population: This outcome measure was not evaluated or analyzed as all subjects received multiple biopsies