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Low- and Zero-dose Contrast-enhanced MRI Using Deep Learning

Award Number: R44EB027560
ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2020
PERIOD OF PERFORMANCE END DATE: 05/31/2023

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Low- and Zero-dose Contrast-enhanced MRI Using Deep Learning - Project Summary Motivation: Gadolinium-based contrast agents (GBCAs) are used in approximately a third of all MRI scans. The unique relaxation parameters of GBCAs create indispensable image contrast for a wide range of clinical applications, such as angiography and tumor detection. However, the usage of GBCAs has been linked to the development of nephrogenic systemic fibrosis (NSF). NSF can be painful, cause severe disability, and even death. The risk of developing NSF prevents millions of patients with advanced chronic kidney disease (CKD) from receiving contrast-enhanced MRI exams. The recent identification of gadolinium deposition within the brain and body has raised additional safety concerns about the usage of GBCAs. Studies have demonstrated increased signal intensity on the unenhanced T1-weighted MR images that is correlated with previous GBCA exposure, and this gadolinium retention is independent of renal function. While initial reports focused on linear GBCAs, more recent reports show that gadolinium deposition occurs with macrocyclic GBCAs as well, albeit at lower levels. FDA has recently issued warnings about gadolinium retention following contrast-enhanced MRI, and required GBCA manufacturers to conduct human and animal studies to further assess the safety of these contrast agents. This project addresses these concerns by developing low-dose and zero-dose contrast-enhanced MRI using artificial intelligence (AI) and deep learning (DL). Approach: This fast-track project has two phases and three aims. Aim 1 (Phase I) is to develop a DL method that can synthesize full-dose contrast-enhanced MR images using pre-contrast images and contrast-enhanced images acquired with only 10% of standard GBCA dose. A software infrastructure will be constructed to seamlessly integrate the DL software between MR scanners and PACS. Aim 2 (Phase II) is to develop a DL method that can synthesize full-dose contrast-enhanced MR images using GBCA-free acquisitions with different image contrast. In Aim 3 (Phase II), we will clinically validate and evaluate both low-dose and zero-dose DL methods, including on patients with mild- to-moderate CKD. Non-inferiority tests and diagnostic performance of the synthesized full-dose images compared to the true full-dose images will be performed. Significance: This work will lead to safer contrast-enhanced MRI. The low-dose and zero-dose contrast-enhanced MRI method will benefit not only millions of patients with advanced CKD, who cannot currently undergo contrast-enhanced MRI, but many more patients with normal kidney function, who are at the risk of gadolinium retention after contrast-enhanced MRI.


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: 2024 ( Subtotal = $0 )
2024	2021	SUBTLE MEDICAL, INC.	883 SANTA CRUZ AVE STE 205	MENLO PARK	CA	94025	SAN MATEO	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	3	2/21/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	SUBTLE MEDICAL, INC.	883 SANTA CRUZ AVE STE 205	MENLO PARK	CA	94025	SAN MATEO	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	3	9/12/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $755,740 )
2021	2021	SUBTLE MEDICAL, INC.	883 SANTA CRUZ AVE STE 205	MENLO PARK	CA	94025	SAN MATEO	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	002	3	8/2/2021	NON-COMPETING CONTINUATION	$755,740
2021	2020	SUBTLE MEDICAL, INC.	883 SANTA CRUZ AVE STE 205	MENLO PARK	CA	94025	SAN MATEO	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	2	11/17/2020	EXTENSION WITH OR WITHOUT FUNDS	$0
2021	2020	SUBTLE MEDICAL, INC.	883 SANTA CRUZ AVE STE 205	MENLO PARK	CA	94025	SAN MATEO	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	001	2	2/1/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $755,740

Issue Date FY: 2020 ( Subtotal = $742,405 )
2020	2020	SUBTLE MEDICAL, INC.	883 SANTA CRUZ AVE STE 205	MENLO PARK	CA	94025	SAN MATEO	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	001	2	7/29/2020	EXTENSION WITH OR WITHOUT FUNDS	$742,405
2020	2019	SUBTLE MEDICAL, INC.	883 SANTA CRUZ AVE STE 205	MENLO PARK	CA	94025	SAN MATEO	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	4/28/2020	NEW	$0
														Subtotal = $742,405

Issue Date FY: 2019 ( Subtotal = $185,379 )
2019	2019	SUBTLE MEDICAL, INC.	883 SANTA CRUZ AVE STE 205	MENLO PARK	CA	94025	SAN MATEO	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	9/13/2019	NEW	$185,379
														Subtotal = $185,379

Grand Total All Awards = $1,683,524

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Low- and Zero-dose Contrast-enhanced MRI Using Deep Learning

Award Number: R44EB027560

ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2020

PERIOD OF PERFORMANCE END DATE: 05/31/2023

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