Pilot Collaborative PET Imaging Trial

PET 成像协作试点试验

• 批准号: 6910712
• 负责人: NORMAN LOUIS FOSTER
• 金额: $ 72.4万
• 依托单位: UNIVERSITY OF UTAH
• 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 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6910712
• 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。临床医生面临的挑战是确定症状是否是由额颞叶痴呆 (FTD) 或阿尔茨海默病 (AD) 等进行性痴呆疾病引起，还是由非痴呆精神疾病引起。目前此类决定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、经过验证的诊断生物标志物来进行更有效和特异性的治疗。 我们的小组收集了初步数据，表明正电子发射断层扫描 SF 氟脱氧葡萄糖（FDG-PET）是一种生物标志物，可以提高 FTD 的准确诊断率。我们提议进行一项为期 3 年的前瞻性多中心试点试验，以在现实的临床环境中评估怀疑 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 个站点将招募 6 名患有认知障碍和提示 FTD 的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，我们将收到扫描结果并提供临床护理；另一个将保持对这些结果不知情，并每 6 个月进行一次协议评估。 18 个月后，一个可以访问所有患者数据（包括某些病例的尸检结果）的共识小组将确定最终诊断。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加准确。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 60 名先前研究的患者的结果。这项研究的结果将对新生物标志物的开发以及 FDG-PET 在 AD 和其他痴呆症评估中的使用产生广泛的影响。 除了其科学目标外，该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。

项目成果

Realizing the potential of positron emission tomography with 18F-fluorodeoxyglucose to improve the treatment of Alzheimer's disease.

认识到 18F-氟脱氧葡萄糖正电子发射断层扫描在改善阿尔茨海默病治疗方面的潜力。

• 发表时间: 2008-01
• 作者: Foster, Norman L;Wang, Angela Y;Tasdizen, Tolga;Fletcher, P Thomas;Hoffman, John M;Koeppe, Robert A
• 通讯作者: Koeppe, Robert A

Strategies for using molecular neuroimaging in dementia.

使用分子神经影像治疗痴呆症的策略。

• 发表时间: 2008
• 作者: Foster; Norman L
• 通讯作者: Norman L