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MR-Guided Precision Conformal Ablation Therapy for Brain Tumors

Award Number: R01CA166379
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/17/2013
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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MR-Guided Precision Conformal Ablation Therapy for Brain Tumors - Project Summary Brain metastases (BM) are the most common site of metastases from systemic cancer, with an incidence of up to 170,000 new cases per year in North America. Untreated BM patients generally live less than two months. Treatment options are currently limited to resective surgery, radiation therapies and chemotherapy. Thermal ablation has been postulated as an alternative therapy, but available devices have significant limitations with respect to conformal spatial control of ablation pattern and access to some regions within the brain. This project proposes development of needle-based therapeutic ultrasound (NBTU) devices and integrated system to accurately target and induce conformal ablation patterns for treatment of tumors and validation in a large animal model. The initial project period resulted in the development of a complete set of tools that utilize real-time magnetic resonance imaging guided robot-assisted (MRgRA) delivery of interstitial NBTU as a neuroablative device, which culminated in two swine survival surgeries to date. This NBTU device offers advantages over transcranial HIFU in that all regions of the brain can be targeted, ablation volumes can be shaped three- dimensionally, and concurrent biopsy is possible. This competitive renewal project will focus on the need to modify the device to prepare for first-in-human trials and to validate the device in a significant animal study. The objectives of this project are to: 1) Develop directional therapeutic ultrasound probes that are configured to produce controlled intensity distribution of energy along both length and angle to allow for conformal ablation patterns based on tumor volume. 2) Optimize the robotic delivery device design to maximize its reachable workspace, and validate this capacity by performing ablations in various brain regions. 3) Improve the interface between the current FDA 510K approved TheraVision therapy planning and monitoring system, MR thermal imaging (MRTI), and MR-guided robotic assist device to allow for “point and click” software use; and 4) In accordance with FDA requirements for a first in man trial, validate the clinically ready version of this system under appropriate design controls by performing survival swine studies that monitor safety and accuracy. An FDA IDE application will be filed in the final stages of this project to prepare for a future first-in-human clinical trial. Successful completion of this project will result in substantial technical and feasibility advancements over the current state-of-the-art for HIFU, including volumetric MR thermal imaging and customized NBTU probes and dosing strategies. This project will lead directly to delivery of a new high-precision treatment option for patients with brain metastases that will provide targeted tumor ablation with minimal collateral damage to surrounding non-targeted tissue.


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	2022	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE RD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	000	10	10/21/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE RD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	000	10	12/20/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $694,325 )
2022	2022	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE RD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	000	10	8/5/2022	NON-COMPETING CONTINUATION	$694,325
														Subtotal = $694,325

Issue Date FY: 2021 ( Subtotal = $706,183 )
2021	2021	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE RD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	000	9	8/3/2021	NON-COMPETING CONTINUATION	$706,183
														Subtotal = $706,183

Issue Date FY: 2020 ( Subtotal = $702,622 )
2020	2020	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE RD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	001	8	8/12/2020	NON-COMPETING CONTINUATION	$702,622
2020	2019	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE RD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	000	7	11/1/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $702,622

Issue Date FY: 2019 ( Subtotal = $678,161 )
2019	2019	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE RD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	002	7	8/23/2019	NON-COMPETING CONTINUATION	$678,161
2019	2018	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE RD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	001	6	1/23/2019	COMPETING CONTINUATION	$46,849
2019	2017	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE RD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	000	5	1/23/2019	NON-COMPETING CONTINUATION	-$46,849
														Subtotal = $678,161

Issue Date FY: 2018 ( Subtotal = $722,235 )
2018	2018	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE RD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	001	6	9/21/2018	COMPETING CONTINUATION	$722,235
2018	2017	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE RD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	000	5	8/29/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $722,235

Issue Date FY: 2017 ( Subtotal = $568,978 )
2017	2017	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE RD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	001	5	6/8/2017	NON-COMPETING CONTINUATION	$56,899
2017	2017	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE RD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	000	5	4/27/2017	NON-COMPETING CONTINUATION	$512,079
														Subtotal = $568,978

Issue Date FY: 2016 ( Subtotal = $592,941 )
2016	2016	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE ROAD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	000	4	4/27/2016	EXTENSION WITH OR WITHOUT FUNDS	$592,941
														Subtotal = $592,941

Issue Date FY: 2015 ( Subtotal = $596,290 )
2015	2015	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE ROAD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	000	3	4/10/2015	NON-COMPETING CONTINUATION	$596,290
														Subtotal = $596,290

Issue Date FY: 2014 ( Subtotal = $591,656 )
2014	2014	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE ROAD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	000	2	5/7/2014	NON-COMPETING CONTINUATION	$591,656
														Subtotal = $591,656

Issue Date FY: 2013 ( Subtotal = $652,276 )
2013	2013	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE ROAD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	001	1	7/1/2013	NEW	$155,794
2013	2013	WORCESTER POLYTECHNIC INSTITUTE	100 INSTITUTE ROAD	WORCESTER	MA	01609	WORCESTER	USA	Cancer Detection and Diagnosis Research	000	1	5/17/2013	NEW	$496,482
														Subtotal = $652,276

Grand Total All Awards = $6,505,667

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MR-Guided Precision Conformal Ablation Therapy for Brain Tumors

Award Number: R01CA166379

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/17/2013

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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