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dMRI-guided pre-operative planning for supra-total resection of high-gradegliomas

Award Number: R01CA278819
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/22/2023
PERIOD OF PERFORMANCE END DATE: 08/31/2029

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dMRI-guided pre-operative planning for supra-total resection of high-gradegliomas - ABSTRACT High-grade gliomas (HGGs) are the most common primary brain malignancy in adults associated with very poor survival rates despite various treatments. Surgery is the current mainstay treatment for HGGs, and the main factor affecting survival rates (in over two decades) has been the increased extent of resection targeting the “visible” contrast-enhancing tumor (CET) seen on conventional contrast-enhanced MR imaging. However, since then research has shown that it is the “invisible” non-enhancing tumor (NET) which leads to progression or recurrence in HGGs by infiltrating the surrounding white matter (WM) tracts. This has led to the adoption of a supratotal resection (SpTR) approach, which includes resection of the `invisible' (microscopic) cancer beyond the visible contrast enhanced margins. SpTR has been shown to result in better patient outcomes with progression-free and overall survival. SpTR is undertaken using a combination of intra-operative techniques but having a pre-op assessment of the functional anatomy will enhance the chances of preserving function and maximizing tumor resection. Thus, the overarching goal of this Academia-Industry partnership (AIP) is to provide a treatment planning tool that will facilitate safe SpTR maximizing the benefit of surgical therapy while preserving neurologic function. The partnership builds on the technical expertise of UPenn for method development, the translational expertise of Synaptive to integrate into a clinically deployable product, and Mount Sinai's clinical expertise in evaluating it on patients. In Aim 1, UPenn will optimize and evaluate a tracking paradigm that provides enhanced visualization of WM fibers in NET. This will entail by combining tissue modeling, fiber tracking and tract delineation in clinically feasible multishell dMRI and optimize the paradigm for reproducibility and generalizability across patients and acquisitions. A comprehensive comparison of the approach to research and clinical paradigm will also be undertaken using retrospective data. The prototype for this tractography paradigm will be integrated into the Synaptive neuro-navigation product incorporating clinical and regulatory needs, with rigorous testing. The design will be optimized to maximize clinical utility assessed through a multi-surgeon evaluation across different Synaptive sites. This will culminate in the creation of an enhanced planning tool. Finally, in Aim 3, a prospective pilot study will be undertaken to evaluate this tool on clinical efficacy for safe SpTR, with patients being longitudinally assessed for neurological deficits. At the end of this study, the extensive evaluations will position the tool to a point of readiness for FDA submission. The AIP will lead to an enhanced pre-operative planning tool to plan safe SpTR, complementing intra-operative functional mapping, fulfilling a crucial unmet clinical need. The extended resection that this tool will facilitate, will potentially lead to extended survival times and hence improve patient outcomes. Thus, this tool is expected to significantly impact the clinical management of brain cancer, by affecting surgical treatment.


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 = $0 )
2025	2023	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Detection and Diagnosis Research	001	3	10/8/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$87,775
2025	2023	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Detection and Diagnosis Research	000	1	10/8/2024	NEW	-$87,775
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $5 )
2024	2023	COHEN VETERANS BIOSCIENCE INC	535 8TH AVE FL 12	NEW YORK	NY	10018	NEW YORK	USA	Cancer Detection and Diagnosis Research	003	2	9/18/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$539,600
2024	2023	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Detection and Diagnosis Research	002	3	9/18/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$539,600
2024	2023	COHEN VETERANS BIOSCIENCE INC	535 8TH AVE FL 12	NEW YORK	NY	10018	NEW YORK	USA	Cancer Detection and Diagnosis Research	001	2	3/28/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$539,601
2024	2023	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Detection and Diagnosis Research	000	1	3/28/2024	NEW	-$539,596
														Subtotal = $5

Issue Date FY: 2023 ( Subtotal = $627,371 )
2023	2023	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Detection and Diagnosis Research	000	1	8/22/2023	NEW	$627,371
														Subtotal = $627,371

Grand Total All Awards = $627,376

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dMRI-guided pre-operative planning for supra-total resection of high-gradegliomas

Award Number: R01CA278819

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/22/2023

PERIOD OF PERFORMANCE END DATE: 08/31/2029

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