Pilot Collaborative PET Imaging Trial

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，提示轻度痴呆。临床医生面临的挑战是确定症状是否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），或非痴呆性精神障碍。目前用于此类决策的诊断算法是主观的，并且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、经验证的诊断生物标志物来进行更有效和更特异的治疗。 我们的小组已经收集了初步的数据，表明正电子发射断层扫描与 SF氟代脱氧葡萄糖（FDG-PET）是一种生物标志物，可以提高FTD的准确诊断。我们提出了一项为期3年的前瞻性多中心初步试验，以在现实的临床环境中评估疑似FTD时FDG-PET的价值。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步。9个研究中心将招募6例有提示FTD的认知损害和行为或语言症状的患者。两名痴呆症专家将使用标准临床方法对每位患者进行评估，并在进行FDG-PET扫描之前做出诊断。然后，其中一人将收到该扫描的结果并提供临床护理;另一人将对这些结果保持盲态，并每6个月进行一次方案评价。18个月后，一个可以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。该研究的主要假设是FDG-PET扫描后的诊断将比之前的诊断更准确。此外，我们将确定FDG-PET结果如何影响医生的信心，患者护理和护理人员的满意度。共识小组还将审查60名先前研究的患者的结果。这项研究的结果将对开发新的生物标志物和使用FDG-PET评估AD和其他痴呆症具有广泛的意义。 除了其科学目的外，这项试点试验还将评估大规模研究所需的受试者选择和共识小组程序以及统一的图像采集和质量控制方法。

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.