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| ID | Type | Description | Link |
|---|---|---|---|
| 8574 | Other Grant/Funding Number | Albert Einstein Society Grant |
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In this proposal, the aim is to examine shear wave elastography (SWE) measurements in diseased native kidneys and correlate them with grades of fibrosis using histological samples.
The overall goals of the proposed study are addressed by the following specific aim.
Specific aim: To determine whether differences exist in elasticity measurements between native kidneys with and without fibrosis.
Hypothesis: Kidneys with higher grades of fibrosis will demonstrate higher measures of tissue elasticity and stiffness compared to kidneys with zero fibrosis.
The proposed project is a prospective cross-sectional study correlating native kidney shear wave elastography (SWE) measurements with histology. Briefly, patients referred for a native kidney biopsy will undergo SWE and the shear wave velocity (SWV) will be correlated with degree of fibrosis determined by a pathologist.
A list of patients who recently underwent a native kidney biopsy will be obtained from the pathology department on a weekly basis. Patients will then be contacted about participating in the study and consented during a follow up visit with their nephrologist.
After their biopsies, patients will be scheduled to come for a renal ultrasound and SWE. SWE examination will be conducted using an ultrasound machine equipped with a Philips Epiq ARFI Shear wave ElastPQ C1-5 mHz transducer. Shear wave velocity will be obtained and an estimate of tissue elasticity (Young's modulus) will be calculated. All measurements will be performed by one of two qualified radiology physicians who will be blinded to the clinical and pathological data. We will allow a period of 90 days to obtain the images after the biopsy; otherwise the patient is no longer eligible to participate.
The primary outcome measure of this study is to determine whether tissue elasticity determined by SWE can assess kidney fibrosis. Linear regression analysis will be performed to describe the relation of the extent of fibrosis and parenchymal stiffness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shear wave elastography group | Experimental | Patients referred for kidney biopsy will then undergo shear wave elastography measurements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shear wave elastography | Device | Ultrasound technique of the kidneys to assess wave elastography. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shear Wave Velocity of Kidney Parenchyma | The shear wave velocity of the kidneys will be determined using the elastography ultrasound machine. This will enable us to calculate the tissue elasticity using a standard formula. Shear wave velocity is measured in meters per second, at a range of 0-5 m/s with the highest number reporting hard consistency (fibrosis - worse outcome). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Naranjo-Tovar, MD | Albert Einstein Healthcare Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein Healthcare Network | Philadelphia | Pennsylvania | 19141 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25546304 | Background | Hu Q, Wang XY, He HG, Wei HM, Kang LK, Qin GC. Acoustic radiation force impulse imaging for non-invasive assessment of renal histopathology in chronic kidney disease. PLoS One. 2014 Dec 29;9(12):e115051. doi: 10.1371/journal.pone.0115051. eCollection 2014. | |
| 26227484 | Result | Samir AE, Allegretti AS, Zhu Q, Dhyani M, Anvari A, Sullivan DA, Trottier CA, Dougherty S, Williams WW, Babitt JL, Wenger J, Thadhani RI, Lin HY. Shear wave elastography in chronic kidney disease: a pilot experience in native kidneys. BMC Nephrol. 2015 Jul 31;16:119. doi: 10.1186/s12882-015-0120-7. |
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Outpatient
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| ID | Title | Description |
|---|---|---|
| FG000 | Shear Wave Elastography Group | Patients referred for kidney biopsy will then undergo shear wave elastography measurements. Shear wave elastography: Ultrasound technique of the kidneys to assess wave elastography. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Shear Wave Elastography Group | Patients referred for kidney biopsy will then undergo shear wave elastography measurements. Shear wave elastography: Ultrasound technique of the kidneys to assess wave elastography. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Shear Wave Velocity of Kidney Parenchyma | The shear wave velocity of the kidneys will be determined using the elastography ultrasound machine. This will enable us to calculate the tissue elasticity using a standard formula. Shear wave velocity is measured in meters per second, at a range of 0-5 m/s with the highest number reporting hard consistency (fibrosis - worse outcome). | Posted | Median | Standard Deviation | meters per second | 6 months |
|
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1 year
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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 | Shear Wave Elastography Group | Patients referred for kidney biopsy will then undergo shear wave elastography measurements. Shear wave elastography: Ultrasound technique of the kidneys to assess wave elastography. |
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Early termination leading to small numbers of subjects analyzed due to technical problems during recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mario Naranjo-Tovar | AlbertEHN | 2157965542 | mario.edu6@hotmail.com |
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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 | May 9, 2016 | Apr 13, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 26426636 | Result | Lee J, Oh YT, Joo DJ, Ma BG, Lee AL, Lee JG, Song SH, Kim SU, Jung DC, Chung YE, Kim YS. Acoustic Radiation Force Impulse Measurement in Renal Transplantation: A Prospective, Longitudinal Study With Protocol Biopsies. Medicine (Baltimore). 2015 Sep;94(39):e1590. doi: 10.1097/MD.0000000000001590. |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |