Partnership for Magnetic Resonance Spectroscopy Biomarker Development
磁共振波谱生物标志物开发合作伙伴关系
基本信息
- 批准号:8929438
- 负责人:
- 金额:$ 69.06万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2015
- 资助国家:美国
- 起止时间:2015-09-01 至 2020-05-31
- 项目状态:已结题
- 来源:
- 关键词:Age-associated memory impairmentAlzheimer&aposs DiseaseAreaAtlasesBiochemicalBiological MarkersBiomedical EngineeringBrainBrain DiseasesBrain regionCentral Nervous System DiseasesCerebrumChildhood Brain NeoplasmClinicClinicalClinical TrialsCollaborationsConsensusDataData AnalysesData QualityDementiaDemyelinating DiseasesDevelopmentDiagnosticDiseaseEarly DiagnosisEarly treatmentEffectivenessEnvironmentEpilepsyFloridaFundingGoalsHereditary DiseaseImaging technologyInfectionInheritedInstitutesInstitutionInternationalInvestigationLaboratoriesMagnetic Resonance ImagingMagnetic Resonance SpectroscopyMetabolicMethodsMichiganMinnesotaMonitorMovement DisordersNerve DegenerationNeurodegenerative DisordersPathologyPatientsPerformancePhasePhysiciansPhysiologic pulsePositioning AttributeProcessProtocols documentationProtonsRecommendationReproducibilityResearchResearch InfrastructureResearch PersonnelSamplingScanningScientistSiteSoftware EngineeringSpecialized CenterSpinocerebellar AtaxiasStandardizationStrokeTechnologyTestingTherapeutic InterventionTrainingTranslationsUnited States National Institutes of HealthUniversitiesValidationVendorbaseclinical research sitecohortdata acquisitionhealthy volunteerindium arsenidemethod developmentmild cognitive impairmentnervous system disorderneurochemistryneuroimagingopen sourcepatient populationprognosticpublic health relevancequantitative imagingresearch clinical testingsimulationtherapy developmenttreatment effecttreatment response
项目摘要
DESCRIPTION (provided by applicant): Clinical trials for neurodegenerative diseases are hampered by the lack of quantitative and objective biomarkers that reflect treatment effects in the brain. Magnetic resonance spectroscopy (MRS) has potential to directly assess disease-modifying effects of therapeutic interventions in the brain. However, MRS has not made the transition to the clinical setting, largely due to lack of standardization of data acquisition and analysis methods and compromised data quality obtained with standard clinical packages, which result in poor reproducibility of neurochemical concentrations. The primary objective of this application is to facilitate translation of advanced MRS technology to the clinical setting ina strategic alliance between MR physicists, software engineers and physician scientists. This Partnership for MRS Biomarker Development is comprised of 3 phases and incorporates a gradual shift from MRI/MRS to clinical expertise at the sites involved: Phase I will establish an MR-technologist ready advanced MRS protocol on two widely-used clinical 3T platforms. An optimized semi-LASER (sLASER) sequence was chosen for this implementation because it is considered a top candidate for recommendation for high fields by the MRS Consensus Group. Phase II will assess the performance of the protocol under ideal conditions (efficacy), namely at sites where MRI/S and clinical trial expertise overlap. We focus on hereditary spinocerebellar ataxias (SCA) because the patient cohorts are well-characterized and they present the greatest need for multi-center investigations to sufficiently sample the patient population in trials. Four sites of the Clinical Research Consortium for Spinocerebellar Ataxias (CRC-SCA), which was formed to provide infrastructure for clinical trials in the common SCAs, will participate in this phase. Finally, Phase III will assess the performance of the protocol under ordinary conditions (effectiveness), i.e. in a clinical setting with rotating MR technologists. This phase will focus o Alzheimer disease (AD), the most common cause of age associated cognitive decline and dementia, and take advantage of large ongoing neuroimaging investigations. This application has a translational focus. The bioengineering focus areas of this project include advanced high field MRI technology for neuroimaging applications, validation and reproducibility assessment of spectral acquisition and analysis methods and non-invasive technology to assist monitoring treatment response in brain disorders. The partnership sites are the University of Minnesota (leading institution), Johns Hopkins University [Phases I and II], Duke University [Phase I], University of Florida [Phase II], Harvard University [Phase II], Mayo Clinic [Phase III] and University of Michigan [Phase III]. The deliverable of this project will be a turn-key advanced MRS data acquisition and analysis protocol that has been comprehensively evaluated in multiple patient cohorts, brain regions, platforms, and institutions, including the clinical settin. A high impact is expected in early diagnosis and treatment of neurodegenerative diseases.
描述(由申请人提供):神经退行性疾病的临床试验因缺乏反映脑中治疗效果的定量和客观生物标志物而受到阻碍。磁共振波谱(MRS)有可能直接评估脑内治疗干预的疾病改善效果。然而,MRS还没有过渡到临床环境,主要是由于缺乏标准化的数据采集和分析方法和妥协的数据质量获得与标准的临床包,这导致在差的神经化学浓度的再现性。本申请的主要目的是通过MR物理学家、软件工程师和医师科学家之间的战略联盟,促进将先进的MRS技术转化为临床环境。MRS生物标志物开发合作伙伴关系由3个阶段组成,并在所涉及的研究中心逐步从MRI/MRS转向临床专业知识:第一阶段将在两个广泛使用的临床3 T平台上建立一个MR技术人员准备好的高级MRS协议。选择优化的半激光(sLASER)序列用于此实施,因为它被认为是MRS共识组推荐高场的首选。II期将评估方案在理想条件下的性能(有效性),即在MRI/S和临床试验专业知识重叠的研究中心。我们专注于遗传性脊髓小脑共济失调(SCA),因为患者队列特征良好,并且最需要多中心调查以在试验中对患者人群进行充分采样。脊髓小脑共济失调临床研究联盟(CRC-SCA)的四个研究中心将参与这一阶段,CRC-SCA的成立是为了为常见SCA的临床试验提供基础设施。最后,III期将评估方案在普通条件下的性能(有效性),即在MR技术人员轮换的临床环境中。该阶段将重点关注阿尔茨海默病(AD),这是与年龄相关的认知衰退和痴呆症的最常见原因,并利用正在进行的大型神经影像学研究。这个应用程序有一个翻译的重点。该项目的生物工程重点领域包括用于神经成像应用的先进高场MRI技术,光谱采集和分析方法的验证和再现性评估,以及辅助监测脑部疾病治疗反应的非侵入性技术。伙伴关系地点是明尼苏达大学(牵头机构)、约翰霍普金斯大学(第一和第二阶段)、杜克大学(第一阶段)、佛罗里达大学(第二阶段)、哈佛大学(第二阶段)、马约诊所(第三阶段)和密歇根大学(第三阶段)。该项目的交付成果将是一个交钥匙的高级MRS数据采集和分析协议,该协议已在多个患者队列、大脑区域、平台和机构(包括临床环境)中进行了全面评估。预计在神经退行性疾病的早期诊断和治疗方面具有很高的影响。
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(1)
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{{ truncateString('Gulin Oz', 18)}}的其他基金
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- 资助金额:
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