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Integration of 5-ALA Fluorescence Lifetime Imaging with Stereotactic Surgical Navigation for Quantitative Real-Time Spatial Localization of Tumor During Neurosurgical Procedures

Award Number: R01CA277380
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/01/2023
PERIOD OF PERFORMANCE END DATE: 12/31/2027

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Integration of 5-ALA Fluorescence Lifetime Imaging with Stereotactic Surgical Navigation for Quantitative Real-Time Spatial Localization of Tumor During Neurosurgical Procedures - PROJECT SUMMARY/ABSTRACT Maximal surgical resection of the most common primary brain cancer, glioblastoma (GBM), has been shown to improve overall survival in a highly morbid disease. However, delineation of residual tumor at the margins of surgical resections can be challenging using conventional techniques, and therefore the use of fluorescence guided surgery (FGS) has emerged as an adjuvant tool for tumor detection. At present, only one agent, 5- aminoleveulinic acid (5-ALA), is approved for detection of GBM during surgery. Metabolism of 5-ALA into protoporphyrin IX (PpIX) is detected qualitatively by wide-field fluorescence imaging through the surgical microscope. This intensity-based detection is non-quantitative and background light-sensitive, requiring the surgeon to work in a dark field. We have developed a fiber-based pulse-excitation time-resolved method for Fluorescence Lifetime Imaging (FLIm) to detect quantitative PpIX fluorescence in real-time under full illumination conditions. Our goal in this study is to integrate the point-scanning FLIm technology with an existing intraoperative stereotactic neuronavigation system produced by BrainLab to spatially co-register FLIm data across the surgical field for applicable surgical guidance. We aim to develop new software and tissue classifiers based on primary patient data, and to apply the integrated technology in a prospective clinical study to demonstrate the benefits for surgical navigation. To achieve the overall goal of developing a new integrated technology which is immediately applicable for routine use in brain tumor resections, we will undertake the following aims: Aim 1) To develop new software for integration of the FLIm device with the BrainLab neuronavigation system for real-time acquisition of spatial positioning of FLIm data and display of the data overlaid on the patient’s imaging in the navigation space. Aim 2) To develop classifiers for surgically resectable tumor based on PpIX fluorescence lifetime thresholds determined through a prospective study correlating FLIm data to tissue biopsies. Aim 3) To validate the accuracy of integrated FLIm-based navigation in identifying residual tumor tissue to facilitate a greater extent of resection in a prospective clinical study.


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 = $541,601 )
2025	2025	UNIVERSITY OF CALIFORNIA, DAVIS	1850 RESEARCH PARK DR STE 300	DAVIS	CA	95618	YOLO	USA	Cancer Detection and Diagnosis Research	000	3	12/19/2024	NON-COMPETING CONTINUATION	$487,441
2025	2025	UNIVERSITY OF CALIFORNIA, DAVIS	1850 RESEARCH PARK DR STE 300	DAVIS	CA	95618	YOLO	USA	Cancer Detection and Diagnosis Research	001	3	6/18/2025	NON-COMPETING CONTINUATION	$54,160
														Subtotal = $541,601

Issue Date FY: 2024 ( Subtotal = $519,183 )
2024	2024	UNIVERSITY OF CALIFORNIA, DAVIS	1850 RESEARCH PARK DR, STE 300	DAVIS	CA	95618	YOLO	USA	Cancer Detection and Diagnosis Research	000	2	12/22/2023	NON-COMPETING CONTINUATION	$491,858
2024	2024	UNIVERSITY OF CALIFORNIA, DAVIS	1850 RESEARCH PARK DR STE 300	DAVIS	CA	95618	YOLO	USA	Cancer Detection and Diagnosis Research	001	2	4/17/2024	NON-COMPETING CONTINUATION	$27,325
														Subtotal = $519,183

Issue Date FY: 2023 ( Subtotal = $590,301 )
2023	2023	UNIVERSITY OF CALIFORNIA, DAVIS	1850 RESEARCH PARK DR, STE 300	DAVIS	CA	95618	YOLO	USA	Cancer Detection and Diagnosis Research	000	1	12/29/2022	NEW	$590,301
														Subtotal = $590,301

Grand Total All Awards = $1,651,085

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Integration of 5-ALA Fluorescence Lifetime Imaging with Stereotactic Surgical Navigation for Quantitative Real-Time Spatial Localization of Tumor During Neurosurgical Procedures

Award Number: R01CA277380

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 01/01/2023

PERIOD OF PERFORMANCE END DATE: 12/31/2027

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