MR-Guided Precision Conformal Ablation Therapy for Brain Tumors
MR 引导脑肿瘤精准适形消融治疗
基本信息
- 批准号:10460989
- 负责人:
- 金额:$ 69.43万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2013
- 资助国家:美国
- 起止时间:2013-05-17 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:3-DimensionalAblationAcousticsAcuteAffectAlgorithmsAlternative TherapiesAnatomyAnimal ModelAnimalsAutopsyBiopsyBrainBrain NeoplasmsBrain regionCadaverCancer PatientClinicalClinical TrialsCollaborationsComputer softwareCoupledCustomDataData SetDevelopmentDevice DesignsDevicesDoseDose-RateEdemaElementsEvaluationExcisionFamily suidaeFocused Ultrasound TherapyFutureGoalsHistopathologyHumanImageIncidenceIndustry CollaborationInstitutionInstitutional Review BoardsLeadLengthLocationMagnetic Resonance ImagingMalignant NeoplasmsMetastatic malignant neoplasm to brainModalityModelingMonitorNeedlesNeoplasm MetastasisNeurologic DeficitNorth AmericaOperative Surgical ProceduresPathologyPatientsPatternPrecision therapeuticsPreparationProtocols documentationQuality of lifeRadiationRadiation therapyRobotRoboticsSafetySelf-Help DevicesShapesSiteSubdural spaceSystemTechnologyTemperatureTestingTherapeuticThermal Ablation TherapyTimeTissuesTranslatingTumor VolumeUltrasonic TherapyUniversitiesValidationWorkalternative treatmentbasebrain tissuechemotherapydesignfirst-in-humanimage guidedimprovedindustry partnerinnovationinstrumentinterstitialminimally invasivemodels and simulationnovelpreclinical trialrobot assistancerobot controlsensorsimulationsuccesstargeted treatmenttooltreatment planningtumortumor ablationultrasoundvalidation studies
项目摘要
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.
项目摘要
脑转移(BM)是系统性癌症最常见的转移部位,其发病率为
到北美每年新增病例17万例。未经治疗的BM患者通常存活不到两个月。
目前的治疗选择仅限于切除手术、放射治疗和化疗。热能
消融已经被认为是一种替代疗法,但现有的设备在以下方面存在显著限制
关于消融模式和进入大脑某些区域的共形空间控制。这个项目
建议开发针基治疗性超声(NBTU)设备和集成系统,以
精确靶向和诱导适形消融模式在大动物肿瘤治疗中的应用及验证
模特。最初的项目阶段导致开发了一套完整的工具,这些工具利用实时
磁共振成像引导机器人辅助(MRgRA)间质NBTU作为神经消融剂的输送
装置,到目前为止,这最终导致了两次猪存活手术。此NBTU设备具有以下优势
经颅HIFU在大脑的所有区域都可以靶向,消融体积可以塑造三个-
从维度上讲,同时进行活检是可能的。此竞争性更新项目将重点关注以下需求
修改该设备,为首次人体试验做准备,并在一项重要的动物实验中验证该设备。这个
该项目的目标是:1)开发定向治疗性超声探头,其配置为
沿长度和角度产生受控的能量强度分布,以允许适形消融
基于肿瘤体积的模式。2)优化机器人送货装置设计,最大限度地提高其可达性
工作空间,并通过在不同大脑区域进行消融来验证这一能力。3)完善界面
在目前FDA 510K批准的TheraVision治疗计划和监测系统之间,
成像(MRTI)和MR引导的机器人辅助设备,以实现软件的“点击”使用;以及4)
根据FDA对首个人试验的要求,验证该系统的临床就绪版本
在适当的设计控制下,通过实施监测安全性和准确性的存活猪研究。一个
FDA的IDE申请将在该项目的最后阶段提交,为未来的第一个人类临床做准备
审判。该项目的成功完成将带来技术和可行性方面的重大进步
目前最先进的HIFU,包括体积磁共振热成像和定制的NBTU探头
以及给药策略。该项目将直接导致交付一种新的高精度治疗方案
脑转移患者将提供靶向肿瘤消融,并对
包围着非靶标组织。
项目成果
期刊论文数量(48)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Mechanical Validation of an MRI Compatible Stereotactic Neurosurgery Robot in Preparation for Pre-Clinical Trials.
- DOI:10.1109/iros.2017.8205979
- 发表时间:2017-09
- 期刊:
- 影响因子:0
- 作者:Nycz CJ;Gondokaryono R;Carvalho P;Patel N;Wartenberg M;Pilitsis JG;Fischer GS
- 通讯作者:Fischer GS
Modeling of Interstitial Ultrasound Ablation for Continuous Applicator Rotation With MR Validation.
- DOI:10.1109/tbme.2020.3023849
- 发表时间:2021-06
- 期刊:
- 影响因子:0
- 作者:Gandomi KY;Carvalho PAWG;Tarasek M;Fiveland EW;Bhushan C;Williams E;Neubauer P;Zhao Z;Pilitsis J;Yeo D;Nycz CJ;Burdette E;Fischer GS
- 通讯作者:Fischer GS
Demonstration and Experimental Validation of Plastic-Encased Resonant Ultrasonic Piezoelectric Actuator for Magnetic Resonance Imaging-Guided Surgical Robots.
- DOI:10.1115/1.4044609
- 发表时间:2020-02-01
- 期刊:
- 影响因子:0
- 作者:Carvalho, Paulo A W G;Nycz, Christopher J;Fischer, Gregory S
- 通讯作者:Fischer, Gregory S
The Influence of Bilateral Subthalamic Nucleus Deep Brain Stimulation on Impulsivity and Prepulse Inhibition in Parkinson's Disease Patients.
- DOI:10.1159/000381558
- 发表时间:2015
- 期刊:
- 影响因子:1.7
- 作者:Gee L;Smith H;De La Cruz P;Campbell J;Fama C;Haller J;Ramirez-Zamora A;Durphy J;Hanspal E;Molho E;Barba A;Shin D;Pilitsis JG
- 通讯作者:Pilitsis JG
NeuroPlan: A Surgical Planning Toolkit for an MRI-Compatible Stereotactic Neurosurgery Robot.
- DOI:10.1109/ismr48346.2021.9661581
- 发表时间:2021-11
- 期刊:
- 影响因子:0
- 作者:Tavakkolmoghaddam, Farid;Rajamani, Dhruv Kool;Szewczyk, Benjamin;Zhao, Zhanyue;Gandomi, Katie;Sekhar, Shreyas Chandra;Pilitsis, Julie;Nycz, Christopher;Fischer, Gregory
- 通讯作者:Fischer, Gregory
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GREGORY S FISCHER其他文献
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{{ truncateString('GREGORY S FISCHER', 18)}}的其他基金
Physician Assistance Technology in Image-guided Robotic Intervention of Prostate
图像引导机器人前列腺介入治疗的医师辅助技术
- 批准号:
10458457 - 财政年份:2021
- 资助金额:
$ 69.43万 - 项目类别:
MR-Guided Precision Conformal Ablation Therapy for Brain Tumors
MR 引导脑肿瘤精准适形消融治疗
- 批准号:
9789837 - 财政年份:2013
- 资助金额:
$ 69.43万 - 项目类别:
MR-Guided Precision Conformal Ablation Therapy for Brain Tumors
MR 引导脑肿瘤精准适形消融治疗
- 批准号:
10001436 - 财政年份:2013
- 资助金额:
$ 69.43万 - 项目类别:
MR-Guided Precision Conformal Ablation Therapy for Brain Tumors
MR 引导脑肿瘤精准适形消融治疗
- 批准号:
8663200 - 财政年份:2013
- 资助金额:
$ 69.43万 - 项目类别:
MR-Guided Precision Conformal Ablation Therapy for Brain Tumors
MR 引导脑肿瘤精准适形消融治疗
- 批准号:
9267348 - 财政年份:2013
- 资助金额:
$ 69.43万 - 项目类别:
MR-Guided Precision Conformal Ablation Therapy for Brain Tumors
MR 引导脑肿瘤精准适形消融治疗
- 批准号:
9052736 - 财政年份:2013
- 资助金额:
$ 69.43万 - 项目类别:
MR-Guided Precision Conformal Ablation Therapy for Brain Tumors
MR 引导脑肿瘤精准适形消融治疗
- 批准号:
8440070 - 财政年份:2013
- 资助金额:
$ 69.43万 - 项目类别:
MR-Guided Precision Conformal Ablation Therapy for Brain Tumors
MR 引导脑肿瘤精准适形消融治疗
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10238063 - 财政年份:2013
- 资助金额:
$ 69.43万 - 项目类别:
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