Instant Kit Synthesis of 62Cu Radiopharmaceuticals

62Cu 放射性药物的即时试剂盒合成

基本信息

批准号：
7257798
负责人：
JEFFREY L LACY
金额：
$ 77.06万
依托单位：
PROPORTIONAL TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-09-15 至 2009-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7257798
关键词：
Address Animals Businesses Cancer Patient Chemistry Clinical Clinical Research Communities Compatible Count Coupled Cyclotrons Daily Development Diagnosis Diagnostic Diagnostic Imaging Diagnostic Neoplasm Staging Dose Drug Formulations Feasibility Studies Fluorine Future Half-Life Harvest Human Hypoxia Image Imaging Techniques Invasive Isotonic Exercise Label Letters Maps Measurement Measures Mechanics Metabolism Methods Modality Myocardial perfusion Organ Perfusion Pharmaceutical Preparations Pharmacy facility Phase Positron-Emission Tomography Preparation Production Puncture procedure Radiopharmaceuticals Range Rattus Research Infrastructure Rest Solutions Sterility Stress Syringes System Techniques Technology Testing Thiosemicarbazones Tracer United States Food and Drug Administration Universities Vial device Wisconsin base copper (II) diacetyl-di(N(4)-methylthiosemicarbazone)cost design dosimetry innovation malignant breast neoplasm miniaturize new technology oncology prevent prototype size success tumor

Address Animals Businesses Cancer Patient Chemistry Clinical Clinical Research Communities Compatible Count Coupled Cyclotrons Daily Development Diagnosis Diagnostic Diagnostic Imaging Diagnostic Neoplasm Staging Dose Drug Formulations Feasibility Studies Fluorine Future Half-Life Harvest Human Hypoxia Image Imaging Techniques Invasive Isotonic Exercise Label Letters Maps Measurement Measures Mechanics Metabolism Methods Modality Myocardial perfusion Organ Perfusion Pharmaceutical Preparations Pharmacy facility Phase Positron-Emission Tomography Preparation Production Puncture procedure Radiopharmaceuticals Range Rattus Research Infrastructure Rest Solutions Sterility Stress Syringes System Techniques Technology Testing Thiosemicarbazones Tracer United States Food and Drug Administration Universities Vial device Wisconsin base copper (II) diacetyl-di(N(4)-methylthiosemicarbazone)cost design dosimetry innovation malignant breast neoplasm miniaturize new technology oncology prevent prototype size success tumor

展开

项目摘要

DESCRIPTION (provided by applicant): Positron Emission Tomography (PET) is a rapidly emerging non-invasive imaging technique with the exceptional ability to provide quantitative functional information. Unfortunately, this modality is currently limited to a single approved radiopharmaceutical agent, 18F-FDG, which measures tumor metabolism. The potential of PET in oncology can be advanced substantially by development of PET tracers that can assess other useful clinical parameters, such as the quantitative measurement of tumor perfusion and hypoxia. Such information is extremely useful for diagnosis and staging of cancer. We propose to develop a micro 62Znfl2Cu generator to produce the 9.7 minute 62Cu PET tracer at very high isotonic concentration and further to develop kit formulations to provide instant synthesis of 62 Cu-bis(thiosemicarbazone) compounds. Phase I will concentrate on demonstrating the feasibility of the combined microgenerator and instant kits for the two perfusion tracers approximately Cu-PTSM and x2CU-ETS, and the hypoxia tracer 62 Cu-ATSM. In Phase II, the microgenerator and kit formulations will be fully developed for human use, INDs will be submitted to the FDA for the three compounds, and finally, limited clinical feasibility studies focusing on serial perfusion and hypoxia imaging completed in a brief imaging session will be performed. The resulting perfusion normalized hypoxia map is expected to produce a highly superior measure of regional tumor hypoxia and thus superior information to guide treatment. The distributable generator produced tracers, together with the widely expanding availability of PET, can have far-reaching benefits in cancer patient treatment and management.

描述（由申请人提供）：正电子发射断层扫描（PET）是一种迅速出现的非侵入性成像技术，具有提供定量功能信息的非凡能力。不幸的是，这种方式目前仅限于单一认可的放射性药物剂18F-FDG，该药物可以测量肿瘤代谢。通过开发可以评估其他有用的临床参数的宠物示踪剂，例如肿瘤灌注和缺氧的定量测量，可以通过开发宠物肿瘤学的潜力来提高肿瘤学的潜力。这些信息对于诊断和分期非常有用。我们建议开发一种微型62ZNFL2CU发电机，以极高的等渗浓度生产9.7分钟的62CU PET示踪剂，并进一步开发套件制剂，以提供62 CU-BIS（硫代含量的果肉）化合物的即时合成。第一阶段将集中于证明对两个灌注示踪剂组合的式微型生物和即时套件的可行性，该灌注示踪剂大约是Cu-PTSM和X2CU-ET，以及缺氧示踪剂62 Cu-ATSM。在II阶段，微型生成剂和套件配方将被充分开发用于人类使用，IND将向FDA提交三种化合物的FDA，最后，将在简短的成像过程中完成，以串行灌注和缺氧成像完成的有限的临床可行性研究。预计所得的灌注归一化缺氧图将产生高度优越的区域肿瘤缺氧，从而产生较高的信息来指导治疗。可分发的发电机生产的示踪剂以及宠物的广泛供应性可以在癌症患者的治疗和管理方面具有深远的好处。