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Development of an INSPIRE System for the Treatment of Inoperable Liver Tumors

Award Number: R01CA276232
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/14/2023
PERIOD OF PERFORMANCE END DATE: 03/31/2028

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Development of an INSPIRE System for the Treatment of Inoperable Liver Tumors - Project Summary Integrated time nanosecond pulse irreversible electroporation (INSPIRE) is a minimally invasive treatment for inoperable solid tumors. This treatment uses ultrashort electrical pulses to destabilize the cell membrane and induce a tunable combination of necrotic and apoptotic cell death within a well-defined volume. The therapy is implemented by introducing one or more electrodes into the tumor then delivering a series of 500ns to 2000ns electrical pulses between an electrode and an external grounding pad. To enable treatment of tumors which occur near our around critical structures active temperature feedback is utilized to limit Joule heating and prevent deleterious thermal injury. Using a combination of ex vivo, in vivo, and computational results we hypothesize that INSPIRE will be a safe and effective treatment for the vast majority of inoperable tumors utilizing a single applicator approach and a compatible pulse generator capable of high voltage outputs when active temperature control is utilized to prevent off-target thermal injury. This proposal will leverage recent developments in high voltage power electronics to develop new instrumentation which is capable of safely administering these treatments in vivo. The safety, efficacy, and reproducibility of these treatments will be evaluated in a combination of in vitro, ex vivo, and in vivo models and the data generated in these studies will be utilized to optimize treatment planning algorithms and clinical applicators designs. The study will culminate with an in vivo study demonstrating the safety and efficacy of these treatments against spontaneous liver tumors in canine veterinary patients.


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 = $564,136 )
2025	2025	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	001	3	5/22/2025	NON-COMPETING CONTINUATION	$56,413
2025	2025	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	000	3	3/3/2025	NON-COMPETING CONTINUATION	$507,723
														Subtotal = $564,136

Issue Date FY: 2024 ( Subtotal = $580,289 )
2024	2024	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	001	2	5/1/2024	NON-COMPETING CONTINUATION	$30,541
2024	2024	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27695	WAKE	USA	Cancer Treatment Research	000	2	4/2/2024	NON-COMPETING CONTINUATION	$549,748
														Subtotal = $580,289

Issue Date FY: 2023 ( Subtotal = $589,104 )
2023	2023	NORTH CAROLINA STATE UNIVERSITY	2601 WOLF VILLAGE WAY	RALEIGH	NC	27607	WAKE	USA	Cancer Treatment Research	000	1	4/14/2023	NEW	$589,104
														Subtotal = $589,104

Grand Total All Awards = $1,733,529

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Development of an INSPIRE System for the Treatment of Inoperable Liver Tumors

Award Number: R01CA276232

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/14/2023

PERIOD OF PERFORMANCE END DATE: 03/31/2028

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