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CLINICAL IMAGING AND RADIATION DOSIMETRY

CLINICAL IMAGING AND RADIATION DOSIMETRY
临床成像和辐射剂量测定
批准号:
7882441
负责人:
JAMES R BADING
金额:
$42.2万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
关键词:
3-DimensionalAdherenceAdministratorAffectAnimalsAnti-CEA AntibodyAntibodiesArchivesAreaArtsAvastinBiodistributionBiometryCalibrationCaliforniaCitiesClinicalClinical ResearchClinical TrialsClinical Trials DesignCollaborationsComplementComputer softwareDataDatabasesDiffusion Magnetic Resonance ImagingDiscipline of Nuclear MedicineDoseDrug KineticsEquipmentExperimental DesignsFunctional ImagingGamma RaysGrantHeadHumanImageImage AnalysisImmunotherapeutic agentImmunotherapyKineticsLabelMalignant NeoplasmsMeasurementMeasuresMetabolicMethodologyMethodsModelingMonoclonal AntibodiesNamesOperative Surgical ProceduresOrganOutcomePatientsPharmaceutical PreparationsPhysicsPhysiologicalPrincipal InvestigatorProceduresProcessProgram Research Project GrantsProtocols documentationProtonsRadiationRadioactivityRadioimmunotherapyRadioisotopesRadiolabeledRadiology SpecialtyRadiometryRelative (related person)ResearchResearch DesignResearch Project GrantsResourcesRetrievalScanningSliceSolid NeoplasmSpectrum AnalysisSystemSystems AnalysisTechniquesTherapeuticTherapy Clinical TrialsTimeTranslatingUniversitiesVeteransWorkanalogantiangiogenesis therapybasebevacizumabclinical applicationdata managementdesigndosimetryexperienceimage processingimaging modalityimprovedinstrumentnovelpharmacokinetic modelpreclinical studyprogramsquality assuranceradiation absorbed doseradiologistradiotracerresearch and developmentresearch studyresponsesingle photon emission computed tomographytreatment responsetumortumor progressiontwo-dimensionaluptake

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中文摘要
翻译
核心A核心主任:Bading,James首席研究员:Raubitschek,Andrew 产品说明: 核心A的总体目标是提供最先进的成像、辐射剂量测定和 新型放射性标记单克隆抗体(MAb)临床试验的药代动力学建模支持, 其他免疫制剂。核心的主要职责是帮助主要研究人员 我们的研究项目优化了成像在其临床研究方案中的使用。为此,核心 将(a)确定和实施目前关于定量成像、内部放射性物质剂量测定的最佳做法, 施用的放射性同位素,以及使用成像来评估和预测肿瘤对治疗的反应;和(B) 根据需要进行研究/开发,以优化临床研究方案中成像的使用。的 核心A团队还将为仪器校准和临床扫描采集提供质量保证。 核心A由两名经验丰富的成像物理学家/辐射剂量学家/动力学建模师领导, 包括功能成像临床应用方面的放射科专家、图像分析师/程序员、 数据库管理员/开发人员和成像研究技术员。一个完整的现代临床 成像设备,包括SPECT-CT和PET-CT(在赠款开始时)。另一 关键设备资源是一个集成良好的图像处理、显示和分析系统, 临床研究。 在药代动力学和辐射剂量测定领域,核心小组将(a)继续进行定量研究, 临床放射免疫治疗(BIT)试验的图像分析和剂量测定计算;(B)补充 SPECT-CT平面成像提高肿瘤和正常组织放射性测量的准确性 器官;(c)实施用于估计辐射吸收剂量的3D、基于体素的方法;(d)评估 SPECT-CT和基于体素的剂量学对估计的肿瘤吸收剂量之间相关性的影响 (e)评估动力学建模的使用,以区分影响肿瘤的因素。 (f)评估抗血管生成剂阿瓦斯丁对肿瘤摄取BIT MAb的影响。 RIT MAbs。核心小组还将在评估治疗反应方面作出重大努力, (a)建立图像响应评估小组(IRAT);(B)实施质量保证计划 用于测量肿瘤对治疗的反应;和(c)评估功能/代谢 在我们的临床治疗试验中测量肿瘤反应(PET/[18 F]FDG)。 核心A直接支持项目1和项目3,这两个项目共同包含所有拟议的临床试验 在接下来的五年里核心A提供成像物理、药代动力学建模和辐射剂量测定 支持核心D(动物核心);核心A还主要负责翻译成像进展 在动物身上发展到临床应用。核心A通过开发建模间接支持项目2 这将有助于预先靶向RIT的临床试验设计。核心A得到以下方面的支持 实验设计和数据管理领域的核心E(生物统计学)。
英文摘要
Core A core Director: Bading, James Principal investigator: Raubitschek, Andrew DESCRIPTION: The overall objective of Core A is to provide state-of-the-art imaging, radiation dosimetry and pharmacokinetic modeling support for clinical trials of novel radiolabeled monoclonal antibodies (MAbs) and other immunotherapeutic agents. The primary responsibility of the Core is to help the principal investigators of our research projects optimize the use of imaging in their clinical study protocols. To that end, the Core will (a) identify and implement current best practices for quantitative imaging, dosimetry of internally administered radioisotopes, and the use of imaging to assess and predict tumor response to therapy; and (b) perform research/development as needed to optimize the use of imaging in the clinical study protocols. The Core A team will also provide quality assurance for instrument calibration and clinical scan acquisition. Core A is led by two highly experienced imaging physicist/radiation dosimetrist/kinetic modelers and also ncludes a radiologist expert in clinical applications of functional imaging, an image analyst/programmer, a data base administrator/developer and an imaging research technician. A full complement of modern clinical maging equipment is available, including SPECT-CT and PET-CT (by the initiation of the grant). Another key equipment resource is a well-integrated image processing, display and analysis system dedicated to linical research studies. In the area of pharmacokinetics and radiation dosimetry, the Core will (a) continue to perform quantitative image analysis and dosimetric calculations for clinical radioimmunotherapy (BIT) trials; (b) supplement planar imaging with SPECT-CT to improve accuracy of radioactivity measurements in tumors and normal organs; (c) implement a 3D, voxel-based method for estimating radiation absorbed dose; (d) evaluate the impact of SPECT-CT and voxel-based dosimetry on the correlation between estimated tumor absorbed dose and response; (e) evaluate the use of kinetic modeling to differentiate among the factors affecting tumor uptake of BIT MAbs; and (f) evaluate the effect of the anti-angiogenesis agent Avastin on tumor uptake of RIT MAbs. The Core will also undertake a major effort in the area of assessment of treatment response by (a) establishing an image response assessment team (IRAT); (b) implementing a quality assurance program for measurements of tumor response to treatment; and (c) evaluating the use of a functional/metabolic measure of tumor response (PET/[18F]FDG) in our clinical therapy trials. Core A directly supports Project 1 and Project 3, which together contain all of the clinical trials proposed for the next five years. Core A provides imaging physics, pharmacokinetic modeling and radiation dosimetry support to Core D (Animal Core); Core A also has primary responsibility for translating imaging advances developed in animals into clinical use. Core A indirectly supports Project 2 by developing modeling methodology that will contribute to clinical trial design for pretargeted RIT. Core A receives support from Core E (Biostatistics) in the areas of experimental design and data management.
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