Novel Minimally Invasive Endobronchial Approach for Lung Cancer Ablation
肺癌消融的新型微创支气管内方法
基本信息
- 批准号:10249490
- 负责人:
- 金额:$ 78.39万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-04-01 至 2023-08-31
- 项目状态:已结题
- 来源:
- 关键词:3-DimensionalAblationAcuteAirAlgorithmsAnimal ModelAnimalsAutopsyBiopsyBronchoscopesCaliberCancerousCathetersCellsChronicClinicalClinical PathologyClinical TrialsComputer softwareContractsCoughingCustomDataDevelopmentDevicesDiagnosisDimensionsDiseaseDistalDoseEngineeringEnsureExcisionFeasibility StudiesFibrosisFistulaFutureGoalsGrantHealthHemorrhageHistopathologyHumanImageIncinerationInfectionInjuryInvestigationIrrigationLengthLesionLifeLobectomyLungLung NeoplasmsMalignant NeoplasmsMalignant neoplasm of lungMedicalMethodsNavigation SystemNoduleNon-Small-Cell Lung CarcinomaOperative Surgical ProceduresPathologyPatientsPeriodicityPeripheralPhasePhysiciansPleuraPneumothoraxPositioning AttributePreparationProductionRadialRadiation therapyRadiofrequency Interstitial AblationRiskRunningSafetySerious Adverse EventSmall Business Innovation Research GrantStainsStructureSystemTechniquesTemperatureTestingTherapeuticThermal Ablation TherapyTimeTissuesTubeUnresectableValidationWorkbasebehavior observationchemotherapyclinical effectcostcost effective treatmentdesigneffective therapyelectric impedanceexperimental studyflexibilityhealinghemodynamicsinnovationinstrumentirritationlung lobelung preservationmeetingsmicrowave ablationminimal riskminimally invasivenovelnovel therapeuticsporcine modelpre-clinicalpreclinical safetypreclinical studyprogramsprototypepulmonary functionrate of changeresearch and developmentrespiratoryresponserobotic systemsafety and feasibilitysafety testingtooltumortumor ablationverification and validation
项目摘要
PROJECT SUMMARY:
Lung cancer is one of the most aggressive and common malignancies world-wide. While surgical resection remains the
best chance of cure, only 20% of patients are eligible for surgery. The remaining patients are managed with combinations
of radiotherapy and chemotherapy and more recently with less invasive stereotactic radiotherapy and percutaneous
thermal ablation. Percutaneous radio-frequency ablation (RFA) or microwave ablation are cost-effective treatment
options for unresectable tumors. This minimally invasive approach, though effective for treatment of some stage 1 and
2 non-small cell lung carcinomas either alone or in combination with other therapies, suffer in terms of their ability to
create thermal destruction of the tumors with sufficient margin without risking serious adverse events like pneumothorax
and collateral injury.
The goal of this proposal is to refine the design of a full-length, endobronchial RFA system that is compatible with the
working channel of a bronchoscope and can achieve thermal ablation of peripheral nodules 2-3 cm in diameter with
minimal risk of pneumothorax. Our innovative approach overcomes past attempts of using RFA to make large lesions
without crossing the airway by combining, in a single device, air aspiration and irrigation flow to increase lesion together
with a custom RF generator algorithm. Our device is designed to be used with currently available tools for lung tumor
biopsy or imaging (e.g., radial EBUS) and can also be used in conjunction with contemporary navigation and robotic
systems.
This project will be completed in several sequential stages. For this Phase II SBIR we will optimize and refine our
innovative approach to RFA, develop a clinical-grade system with verification and validation tests, and demonstrate
safety and controllability in preclinical studies. The information obtained in this grant will be used directly to guide
EFS-IDE submission with the FDA as part of a future phase of the grant.
项目概要:
肺癌是世界范围内最具侵袭性和最常见的恶性肿瘤之一。虽然手术切除仍然是
治愈的机会最大,只有20%的患者适合手术。其余患者采用联合治疗
放疗和化疗,以及最近的微创立体定向放疗和经皮治疗
热消融。经皮射频消融 (RFA) 或微波消融是具有成本效益的治疗方法
不可切除肿瘤的选择。这种微创方法虽然对某些 1 期和
2 非小细胞肺癌无论是单独治疗还是与其他治疗联合治疗,都会受到其治疗能力的影响
对具有足够边缘的肿瘤进行热破坏,而不会产生气胸等严重不良事件的风险
和附带伤害。
该提案的目标是完善全长支气管内 RFA 系统的设计,该系统与
支气管镜工作通道,可实现直径2-3cm周围结节的热消融
气胸的风险最小。我们的创新方法克服了过去使用 RFA 制造大病灶的尝试
通过在单个设备中结合空气抽吸和冲洗流来增加病变,无需穿过气道
使用定制的射频发生器算法。我们的设备设计用于与当前可用的肺部肿瘤工具一起使用
活检或成像(例如,径向 EBUS),也可与现代导航和机器人结合使用
系统。
该项目将分几个连续阶段完成。对于第二阶段 SBIR,我们将优化和完善我们的
RFA 的创新方法,开发具有验证和验证测试的临床级系统,并证明
临床前研究的安全性和可控性。本次赠款中获得的信息将直接用于指导
作为未来阶段拨款的一部分,向 FDA 提交 EFS-IDE 申请。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Howard Levin其他文献
Howard Levin的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Howard Levin', 18)}}的其他基金
Minimally Invasive High Intensity Therapeutic Ultrasound for the Treatment of Obstructive Hypertrophic Cardiomyopathy
微创高强度超声治疗梗阻性肥厚型心肌病
- 批准号:
10603460 - 财政年份:2023
- 资助金额:
$ 78.39万 - 项目类别:
Minimally Invasive High Intensity Therapeutic Ultrasound for the Treatment of Obstructive Hypertrophic Cardiomyopathy
微创高强度超声治疗梗阻性肥厚型心肌病
- 批准号:
10851470 - 财政年份:2023
- 资助金额:
$ 78.39万 - 项目类别:
Novel Minimally Invasive Endobronchial Approach for Lung Cancer Ablation
肺癌消融的新型微创支气管内方法
- 批准号:
10495201 - 财政年份:2019
- 资助金额:
$ 78.39万 - 项目类别:
相似海外基金
心房細動に対するPulsed Field Ablationの組織創傷治癒過程を明らかにする網羅的研究
阐明房颤脉冲场消融组织伤口愈合过程的综合研究
- 批准号:
24K11201 - 财政年份:2024
- 资助金额:
$ 78.39万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Targeted ablation of cerebral atherosclerosis using supramolecular self-assembly
利用超分子自组装靶向消融脑动脉粥样硬化
- 批准号:
24K21101 - 财政年份:2024
- 资助金额:
$ 78.39万 - 项目类别:
Grant-in-Aid for Early-Career Scientists
遅延造影心臓MRIによる心房細動Ablation冷却効果の比較:28 vs. 31 mm Cryoballoon
使用延迟对比增强心脏 MRI 比较房颤消融冷却效果:28 毫米与 31 毫米 Cryoballoon
- 批准号:
24K11281 - 财政年份:2024
- 资助金额:
$ 78.39万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
CAREER: Heat Penetration Depth and Direction Control with Closed-Loop Device for Precision Ablation
职业:利用闭环装置控制热穿透深度和方向,实现精确烧蚀
- 批准号:
2338890 - 财政年份:2024
- 资助金额:
$ 78.39万 - 项目类别:
Continuing Grant
Collaborative Research: RUI: Frontal Ablation Processes on Lake-terminating Glaciers and their Role in Glacier Change
合作研究:RUI:湖终止冰川的锋面消融过程及其在冰川变化中的作用
- 批准号:
2334777 - 财政年份:2024
- 资助金额:
$ 78.39万 - 项目类别:
Continuing Grant
Collaborative Research: RUI: Frontal Ablation Processes on Lake-terminating Glaciers and their Role in Glacier Change
合作研究:RUI:湖终止冰川的锋面消融过程及其在冰川变化中的作用
- 批准号:
2334775 - 财政年份:2024
- 资助金额:
$ 78.39万 - 项目类别:
Continuing Grant
InSPACE-VT_Development and Validation of Virtual Pace Mapping to Guide Catheter Ablation of Ventricular Tachycardia
InSPACE-VT_虚拟起搏测绘的开发和验证以指导室性心动过速导管消融
- 批准号:
EP/Z001145/1 - 财政年份:2024
- 资助金额:
$ 78.39万 - 项目类别:
Fellowship
Collaborative Research: RUI: Frontal Ablation Processes on Lake-terminating Glaciers and their Role in Glacier Change
合作研究:RUI:湖终止冰川的锋面消融过程及其在冰川变化中的作用
- 批准号:
2334776 - 财政年份:2024
- 资助金额:
$ 78.39万 - 项目类别:
Continuing Grant
MRI: Acquisition of a Laser Ablation - Inductively Coupled Plasma - Triple Quadrupole - Mass Spectrometer (LA-ICP-QQQ-MS) System For Research and Education
MRI:获取用于研究和教育的激光烧蚀 - 电感耦合等离子体 - 三重四极杆 - 质谱仪 (LA-ICP-MS/MS) 系统
- 批准号:
2320040 - 财政年份:2023
- 资助金额:
$ 78.39万 - 项目类别:
Standard Grant
Collaborative Research: CDS&E: An experimentally validated, interactive, data-enabled scientific computing platform for cardiac tissue ablation characterization and monitoring
合作研究:CDS
- 批准号:
2245152 - 财政年份:2023
- 资助金额:
$ 78.39万 - 项目类别:
Standard Grant