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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| For Cause | Experimental | For cause biopsies to evaluate a recent rise in serum creatinine. |
|
| Surveillance | Experimental | Surveillance biopsies done after transplant mostly looking for subclinical rejection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optison | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal Biopsy | Number of subjects with abnormal biopsies in either the primary or secondary biopsy location, by diagnosis from a clinical pathologist | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With a Higher Degree of Renal Transplant Rejection Using Multiple Biopsies Compared to a Single Biopsy. | 1 year |
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Inclusion
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| J Kriegshauser, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Abnormal Biopsy | Number of subjects with abnormal biopsies in either the primary or secondary biopsy location, by diagnosis from a clinical pathologist | Posted | Count of Participants | Participants | 1 year |
|
Adverse events were collected from time of biopsy to 1 week post biopsy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Bleeding Complications | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Scott Kriegshauser | Mayo Clinic | 480-342-5664 | skriegshauser@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 26, 2014 | Feb 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C099458 | FS 069 |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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. |
|
| 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. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Serum Creatinine | Mean | Standard Deviation | mg/dL |
|
| OG001 | 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. |
|
|
| Secondary | Number of Patients With a Higher Degree of Renal Transplant Rejection Using Multiple Biopsies Compared to a Single Biopsy. | This outcome measure was not evaluated or analyzed as all subjects received multiple biopsies | Posted | 1 year |
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 20 | 1 | 20 | 0 | 20 |
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