Pilot Collaborative PET Imaging Trial

PET 成像协作试点试验

• 批准号: 6671836
• 负责人: NORMAN LOUIS FOSTER
• 金额: $ 89.57万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6671836
• 关键词: Alzheimer's disease; bioimaging /biomedical imaging; biomarker; brain imaging /visualization /scanning; clinical research; clinical trials; cognition disorders; cooperative study; dementia; deoxyglucose; diagnosis quality /standard; frontal lobe /cortex; human subject; image processing; longitudinal human study; mental disorder diagnosis; neuropsychological tests; positron emission tomography; questionnaires

DESCRIPTION (provided by applicant): Older adults commonly develop thinking problems and disturbing behavior changes suggesting mild dementia. The challenge confronting clinicians is to determine whether symptoms are due to a progressive dementing illness such as frontotemporal dementia (FTD) or Alzheimer's disease (AD), or a non-dementing psychiatric disorder. Current diagnostic algorithms for such decisions are subjective and based on clinical history and examination, or patients can be observed until the outcome is obvious. Practical, validated diagnostic biomarkers now are urgently needed for more effective and specific treatments. Our group has collected preliminary data suggesting positron emission tomography with SF fluorodeoxyglucose (FDG-PET) is a biomarker that can improve the accurate diagnosis of FTD. We propose a 3-year, prospective, multi-center pilot trial to evaluate in a realistic clinical setting the value of FDG-PET when FTD is suspected. A pilot trial rather than a full-scale study is proposed, because many scientific and logistic advances are necessary first. Nine sites will recruit 6 patients with cognitive impairment and behavioral or language symptoms suggestive of FTD. Two dementia specialists will evaluate each patient using standard clinical methods and make a diagnosis before performing an FDG-PET scan. One then will receive the results of this scan and provide clinical care; the other will remain blinded to these results and perform protocol evaluations every 6 months. After 18 months, a consensus panel with access to all of the patient's data, including autopsy findings in some cases, will determine the final diagnosis. The primary hypothesis of the study is that diagnoses after the FDG-PET scan will be significantly more accurate than those before. In addition, we will determine how FDG-PET results affect physician confidence, patient care and caregiver satisfaction. The consensus panel also will review the outcome of 60 previously studied patients. The results of this study will have broad implications for the development of new biomarkers and the use of FDG-PET in the evaluation of AD and other dementias. In addition to its scientific aims, this pilot trial also will evaluate subject selection and consensus panel procedures and uniform image acquisition and quality control methods needed for the large-scale study.

描述(由申请人提供)：老年人通常会出现思维问题和令人不安的行为变化，表明患有轻度痴呆症。临床医生面临的挑战是确定症状是由于进行性痴呆疾病，如额颞叶痴呆(FTD)或阿尔茨海默病(AD)，还是非痴呆精神障碍。目前用于此类决定的诊断算法是主观的，基于临床病史和检查，或者可以观察患者，直到结果明显。现在迫切需要实用的、有效的诊断生物标记物来进行更有效和具体的治疗。 我们小组已经收集了初步数据，表明正电子发射断层扫描 氟代脱氧葡萄糖(FDG-PET)是提高FTD诊断准确率的生物标志物。我们建议进行一项为期3年的前瞻性多中心试点试验，以评估FDG-PET在怀疑FTD时的临床价值。建议进行试点试验，而不是全面研究，因为首先需要许多科学和后勤方面的进展。九个网站将招募6名认知障碍和行为或语言症状提示FTD的患者。两名痴呆症专家将使用标准的临床方法对每个患者进行评估，并在进行FDG-PET扫描之前做出诊断。其中一人将收到扫描结果并提供临床护理；另一人将对这些结果视而不见，并每6个月进行一次方案评估。18个月后，一个能够获得所有患者数据的共识小组，包括某些情况下的尸检结果，将确定最终诊断。这项研究的主要假设是，FDG-PET扫描后的诊断将明显比之前更准确。此外，我们将确定FDG-PET结果如何影响医生信心、患者护理和护理人员满意度。共识小组还将审查之前研究的60名患者的结果。这项研究的结果将对开发新的生物标记物和使用FDG-PET评估AD和其他痴呆具有广泛的意义。 除了其科学目标外，这项试点试验还将评估大规模研究所需的受试者选择和协商一致的小组程序以及统一的图像获取和质量控制方法。