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（由申请人提供）：近年来，减少医学成像电离辐射剂量负担的目标已获得了很大的可见性，但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剂量的实质性变化可能影响图像质量、定量读数和诊断置信度。使用18F-FDG的PET/CT是肿瘤诊断和治疗干预评估的基本成像程序。虽然目前的研究正在探索用于衰减扫描的低剂量CT技术，但这项创新的I期试验将测试和验证与当前标准护理PET/CT相比的低FDG剂量。在目标1中，我们希望通过在四种不同的最先进的PET/CT系统上进行的个体内交叉设计试验（作为个体子研究），验证当前临床护理标准FDG剂量与降低60%剂量水平的诊断等效性。在目标2中，我们将通过比较注射后60 min与注射后75 min进行的全身扫描，验证PET示踪剂的剂量降低不会改变摄取变化的可检测性。与此同时，我们将评估在此时间窗内个体内发现的变化，这是使用FDG PET评估反应的临床试验的重要考虑因素。在目标3中，我们将确认模拟和实际低剂量PET扫描之间的等效性。我们的初步数据表明，模拟低剂量PET图像的标准剂量采集PET扫描的分段重建是有效的和预测的幻影实验，并应能够模拟在较低剂量水平的临床扫描。一旦这种模拟方法得到验证，我们可以简化PET示踪剂剂量发现研究，并指导临床实践的示踪剂剂量优化。由于大幅降低剂量的能力可能会受到供应商特定PET/CT系统设计的影响，我们将使用三大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进行子研究。我们的总体目标是从根本上降低当前标准治疗和临床试验方案中的FDG剂量，以便通过前瞻性试验验证肿瘤成像，从而在不影响诊断和定量能力的情况下大幅降低患者和相关护理人员的辐射负担。