Non-Invasive Evaluation of Transplant Kidney Using OCT
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Procedure/Surgery: Transplantation: OCT of Kidney Transplant
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Kidney Disease focused on measuring Kidney, Transplantation, Imaging, Renal function, Optical Coherence Tomography
Eligibility Criteria
Inclusion Criteria: Undergoing Kidney Transplant -
Exclusion Criteria: None
-
Sites / Locations
- Georgetown University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OCT Imaging
Arm Description
OCT imaging of the kidneys prior to and following their transplant
Outcomes
Primary Outcome Measures
Non-Invasive Evaluation of Transplant Kidney using OCT
The outcome from these studies is to show significance differences in the donor kidneys of the three patient populations (i.e., immediate graft function, slow graft function and delayed graft function) using OCT imaging.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02084966
Brief Title
Non-Invasive Evaluation of Transplant Kidney Using OCT
Official Title
Non-Invasive Evaluation of Transplant Kidney Using OCT
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Optical coherence tomography (OCT) is a rapidly emerging imaging modality that can function as a type of "optical biopsy", providing non-invasive cross-sectional images of tissue architectural morphology in situ and in real-time. This proposal will demonstrate that OCT has the ability to provide novel and valuable histopathological information regarding donor kidneys that can be used to predict post-transplant renal function. These investigations will result in a major breakthrough in increasing the number of healthy kidneys available for transplantation by making the most efficient use of available donor kidneys, eliminating the possible use of bad donor kidneys, providing an accurate measure of expected post-transplant renal function, and allowing better distinction between post-transplant immunological rejection and ischemic-induced acute renal failure.
Detailed Description
What will be assessed: Kidney pathology will be assessed. Specifically, optical coherence tomography (OCT) will be used to observe the pathology of the kidney uriniferous tubules. The proximal convoluted tubules that make up most of the kidney uriniferous tubules and parenchyma in the outer cortex of the kidney (i.e., the portion of the kidney subjacent to the outer kidney capsule) are sensitive indicators of damage to the kidneys. When damaged due to ischemia (i.e., a lack of blood flow), these tubules swell and cellular debris is released into the lumens of these tubules.
Why is this data important: Damage to the kidney proximal tubules, known as acute tubular necrosis (ATN), is the most common cause of poor post-transplant kidney function following transplant. It has been shown that determining the extent of ATN is a good indicator of post-transplant renal function.
How will the data be collected: The histopathology describe above (i.e., the pathology of the kidney tubules) will be collected using optical coherence tomography (OCT). OCT is a rapidly emerging imaging modality that can function as a type of "optical biopsy", providing non-invasive cross-sectional images of tissue architectural pathology in situ and in real-time. OCT is similar to ultrasound, but uses light waves instead of sound waves to obtain high-resolution imaging. The ability of OCT of obtain high-resolution images is necessary in order to observe the pathological changes describe above (i.e., damage to the kidney tubules). Algorithms will be developed as a result of this investigation in order to assist in the prediction of ATN and post-transplant kidney function.
What factors will be measured to determine post-transplant kidney function: The factors that will be used to measure post-transplant renal function include serum creatinine, BUN and glomerular filtration rates (GFR). This data will be collected by examining the surgical and laboratory reports for each patient. The data will be collected daily for the first two weeks following transplant and biweekly for the next six months following transplant. Six months following transplant, this data will be collected every 3 months until conclusion of study (i.e., 4 years). The patient data will be stored on password-protected files on a password-protected computer. The data will be available only to the principal investigator and the co-investigators in this study. A nephrologist fellow who will report directly to the principal investigator will collect the data. The principal investigator will verify data accuracy and protocol compliance. A biostatistician who will be blinded as to patient identity will independently analyze the data. If the data is published, only the parameters listed above and related to post-transplant renal function will be reported. No names will be associated with publication of the collected kidney transplant data. The principal investigator and the biostatistician will monitor this data and any indications of potential harm to the patient will be reported immediately to the Institutional Review Board (IRB).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Kidney, Transplantation, Imaging, Renal function, Optical Coherence Tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCT Imaging
Arm Type
Experimental
Arm Description
OCT imaging of the kidneys prior to and following their transplant
Intervention Type
Procedure
Intervention Name(s)
Procedure/Surgery: Transplantation: OCT of Kidney Transplant
Intervention Description
Device: Optical Coherence Tomography of Kidney Transplant
Primary Outcome Measure Information:
Title
Non-Invasive Evaluation of Transplant Kidney using OCT
Description
The outcome from these studies is to show significance differences in the donor kidneys of the three patient populations (i.e., immediate graft function, slow graft function and delayed graft function) using OCT imaging.
Time Frame
Up to 4 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing Kidney Transplant -
Exclusion Criteria: None
-
Facility Information:
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Non-Invasive Evaluation of Transplant Kidney Using OCT
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