Validating Low FDG Dose PET/CT compared to current Standard of Care Dose PET/CT

验证低 FDG 剂量 PET/CT 与当前护理标准剂量 PET/CT 的比较

• 批准号: 9086293
• 负责人: MICHAEL V KNOPP
• 金额: $ 35.23万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-06-15 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9086293
• 关键词: Affect; Blinded; Cancer Patient; Characteristics; Clinical; Clinical Trials; Clinical trial protocol document; Communities; Crossover Design; Data; Diagnosis; Diagnostic; Disease; Dose; Evaluation; Event; Future; Generations; Goals; Image; Imaging Techniques; Individual; Injection of therapeutic agent; Institution; Ionizing radiation; Lesion; Manufacturer Name; Medical Imaging; Methodology; Monitor; Morphologic artifacts; PET/CT scan; Patient Care; Patients; Pharmacologic Substance; Phase; Population; Positron-Emission Tomography; Practice Guidelines; Protocols documentation; Radiation; Radioactive; Radiopharmaceuticals; Reader; Recommendation; Research; Sampling; Scanning; System; Techniques; Technology; Testing; Therapeutic Intervention; Time; Tissues; Tracer; Translating; Validation; Variant; Vendor; Visual; attenuation; base; cancer imaging; clinical care; clinical practice; design; detector; digital; fluorodeoxyglucose positron emission tomography; imaging agent; innovation; low-dose spiral CT; next generation; phase I trial; prospective; public health relevance; quantitative imaging; radiotracer; reconstruction; research clinical testing; research study; response; simulation; standard of care; uptake; whole body imaging

 DESCRIPTION (provided by applicant): The goal to reduce the ionizing radiation dose burden from medical imaging has gained substantial visibility in recent years, however we require evidence to change current practice guidelines as substantial change in dose of the imaging radiopharmaceutical can affect image quality, quantitative readouts and diagnostic confidence. PET/CT using 18F-FDG is an essential imaging procedure for oncologic diagnosis and assessment of therapeutic interventions. While current studies are exploring low dose CT techniques for the attenuation scan, this innovative Phase I trial will test and validate low FDG dosing compared to current standard of care PET/CT. In Aim 1, we want to validate the diagnostic equivalency of current standard of clinical care FDG dosing to a 60% reduced dose level by an intra-individual crossover designed trial performed as individual sub-studies on four different state-of-the-art PET/CT systems. In Aim 2, we will validate that such a dose reduction of PET tracer does not alter the detectability of uptake changes by comparing a whole-body scan performed at 60 min post injection with that at 75 min p.i. At the same time, we will assess the variations that can be found intra-individually within this time window, an important consideration for clinical trials that use FDG PET to assess response. In Aim 3, we will validate the equivalence between simulated and actual low dose PET scans performed. Our preliminary data show that simulation of lower dose PET images derived by segmented reconstruction of standard dose acquired PET scans is valid and predictive for phantom experiments, and should be able to emulate clinical scans at lower dose levels. Once such a simulation approach is validated, we can simplify PET tracer dose finding studies and guide clinical practice for tracer dose optimizations. As the ability to substantially reduce dose can be impacted by vendor specific PET/CT system designs, we will perform sub-studies, using both the current generation systems from the three major manufacturers and the first available next generation digital detector system. Our overall goal is to radically reduce the FDG dose in current standard of care and clinical trial protocols for oncologic imaging validated by a prospective trial and thereby enabling to substantially reduce the radiation burden to patients and associated caretakers without impacting diagnostic and quantitative capabilities.

 描述（由适用提供）：近年来，减少医学成像的电离辐射剂量燃烧的目的已获得了可见性，但是我们需要证据来改变当前的实践指南，因为成像放射性药物的剂量发生了很大变化，可以影响图像质量，定量读数和诊断信心。使用18F-FDG的PET/CT是肿瘤学诊断和评估治疗干预措施的必不可少的成像程序。尽管目前的研究正在探索衰减扫描的低剂量CT技术，但与当前的护理PET/CT标准相比，这项创新的I期试验将测试并验证低FDG剂量。在AIM 1中，我们希望通过一个个体内部的跨界设计试验来验证当前临床护理FDG剂量的诊断等效性，从而降低了剂量水平，该试验是在四种不同的最先进的PET/CT系统上进行的单个子研究。在AIM 2中，我们将验证宠物示踪剂的这种剂量减少不会通过比较注射后60分钟进行的全身扫描与75分钟P.I的全身扫描来改变摄取变化的可检测性。同时，我们将评估可以在此时间窗口中在个人内发现的变化，这是使用FDG PET评估反应的临床试验的重要考虑因素。 AIM 3，我们将验证进行模拟和实际进行低剂量PET扫描之间的等效性。我们的初步数据表明，通过分段的标准剂量获得的PET扫描对较低剂量的PET图像进行模拟是有效的，并且可以预测幻影实验，并且应该能够在较低剂量水平上模仿临床扫描。一旦验证了这种模拟方法，我们就可以简化宠物示踪剂的剂量研究研究并指导示踪剂剂量优化的临床实践。由于特定于供应商的PET/CT系统设计可以影响实质性降低剂量的能力，因此我们将使用来自三个主要制造商的当前一代系统和第一个可用的下一代数字探测器系统来执行替代。我们的总体目标是从目前的护理标准和临床试验方案中从根本上减少通过前瞻性试验验证的肿瘤学成像的FDG剂量，从而实现了对患者和相关护理人员的辐射燃烧，而不会影响诊断和定量功能。