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Automatic Wide-Field Optical Coherence Tomography for Assessment of Transplant Kidney Viability

Award Number: R01DK133717
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2022
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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Automatic Wide-Field Optical Coherence Tomography for Assessment of Transplant Kidney Viability - Summary There is a worldwide shortage of kidneys for transplantation due mainly to the fact that there is no reliable means to determine the viability of kidneys available for transplant. There are unmet clinical needs to reduce the >8,000 deaths that occur each year from failures of finding viable kidney matches for transplant, to reduce the nearly 4- year time on donor waitlists, and to reduce the number of failed transplants. The current process for screening deceased donor kidneys uses two methods: 1) pathological scores based on anatomical features from a biopsy (tubules, glomeruli, etc.) and 2) the Kidney Donor Profile Index (KDPI) derived from the donor’s medical history (hypertension, diabetes, weight, etc.). However, clinical research indicates that those current methods have limited discriminative power. Optical coherence tomography (OCT) is an imaging technology that can obtain high-resolution, non-invasive, cross-sectional images of biological tissues in situ and in real time. We have demonstrated that OCT can provide non-invasive, real-time, histopathological information of the kidney that is impossible to obtain using any other known procedure. We have demonstrated that OCT imaging of human kidney histopathology both prior to and following their transplant can be used to predict post-transplant renal function. Furthermore, these preliminary trials have demonstrated that OCT imaging of human donor kidneys with a hand-held unit in the operating room is safe and that the entire kidney can be evaluated within a relatively short period of time. From a recently finished clinical study with 169 human transplant kidneys, we found that in the expanded criteria donor (ECD) kidneys (or marginal kidneys), increased tubular lumen diameter was able to predict delayed graft function (DGF) prior to implantation. In this proposal, we will develop a novel OCT device with intelligent scanning and deep learning to evaluate donor kidney viability before transplant. By scanning the whole kidney surface, our device intends to eliminate the uncertainty created by the biopsy/KDPI paradigm. The OCT imaging studies will be correlated with post-transplant renal function in order to establish imaging algorithms and guidelines for OCT imaging of kidneys prior to their transplant. Our central hypothesis is that more comprehensive morphological parameters as measured by OCT can be used to determine post-transplantation renal function. The specific aims of this proposal are: 1) Develop robot-assisted automatic 3D scanning OCT imaging device to image human kidneys prior to their transplantation. 2) Develop deep-learning-based image processing algorithms to quantitatively assess the OCT parameters as indicators of the functional status of kidneys, using histology scoring system as the gold standard. 3) Derive the diagnostic criteria for assessing transplant kidney function and perform prospective clinical studies to assess the accuracy of predicting post- transplant function using OCT.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $609,939 )
2025	2025	UNIVERSITY OF MASSACHUSETTS	101 COMMONWEALTH AVE	AMHERST	MA	01003	HAMPSHIRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	7/22/2025	NON-COMPETING CONTINUATION	$609,939
														Subtotal = $609,939

Issue Date FY: 2024 ( Subtotal = $594,454 )
2024	2024	UNIVERSITY OF MASSACHUSETTS	101 COMMONWEALTH AVE	AMHERST	MA	01003	HAMPSHIRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	8/1/2024	NON-COMPETING CONTINUATION	$594,454
2024	2023	UNIVERSITY OF MASSACHUSETTS	COMMONWEALTH AVE	AMHERST	MA	01003	HAMPSHIRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/8/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $594,454

Issue Date FY: 2023 ( Subtotal = $626,318 )
2023	2023	UNIVERSITY OF MASSACHUSETTS	COMMONWEALTH AVE	AMHERST	MA	01003	HAMPSHIRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	8/1/2023	NON-COMPETING CONTINUATION	$626,318
														Subtotal = $626,318

Issue Date FY: 2022 ( Subtotal = $671,945 )
2022	2022	UNIVERSITY OF MASSACHUSETTS	COMMONWEALTH AVE	AMHERST	MA	01003	HAMPSHIRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	9/16/2022	NEW	$0
2022	2022	UNIVERSITY OF MASSACHUSETTS	COMMONWEALTH AVE	AMHERST	MA	01003	HAMPSHIRE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/8/2022	NEW	$671,945
														Subtotal = $671,945

Grand Total All Awards = $2,502,656

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Automatic Wide-Field Optical Coherence Tomography for Assessment of Transplant Kidney Viability

Award Number: R01DK133717

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2022

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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