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AI-Enabled Echocardiographic Biomarkers and Real-World Data for Predicting Cancer Therapy-Related Cardiac Dysfunction

Award Number: U01FD008704
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/22/2025
PERIOD OF PERFORMANCE END DATE: 08/31/2028

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AI-Enabled Echocardiographic Biomarkers and Real-World Data for Predicting Cancer Therapy-Related Cardiac Dysfunction - Abstract: Cancer survivors have up to a 42% higher risk of cardiac dysfunction than non-cancer populations, in part due to sequelae of cardiotoxic cancer therapies—collectively termed cancer therapy–related cardiac dysfunction (CTRCD). Yet current surveillance strategies suffer from low sensitivity, poor reproducibility, and lack of personalization. This proposal aims to transform cardio-oncology care by integrating FDA-cleared artificial intelligence (AI) echocardiographic biomarkers with real-world electronic health record (EHR) data to improve early detection and risk stratification of CTRCD. Leveraging a diverse cohort of over 34,000 patients treated with cardiotoxic therapies within an integrated healthcare system with comprehensive data, we will apply validated AI models to archived echocardiograms to identify subclinical cardiac dysfunction and develop predictive models that guide personalized surveillance. Specific aims include: (1) evaluating AI-derived biomarkers for early and standardized detection of CTRCD, and (2) developing and validating multimodal predictive models combining AI-echo and EHR data. This work will generate regulatory-grade evidence to inform FDA guidance, improve clinical outcomes, and establish a scalable framework for cardio-oncology surveillance in real-world settings.


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: 2026 ( Subtotal = $0 )
2026	2025	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Food and Drug Administration Research	000	1	5/18/2026	NEW	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $1,498,464 )
2025	2025	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Food and Drug Administration Research	000	1	9/18/2025	NEW	$1,498,464
														Subtotal = $1,498,464

Grand Total All Awards = $1,498,464

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AI-Enabled Echocardiographic Biomarkers and Real-World Data for Predicting Cancer Therapy-Related Cardiac Dysfunction

Award Number: U01FD008704

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/22/2025

PERIOD OF PERFORMANCE END DATE: 08/31/2028

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