REGIONAL BIODISTRIBUTION & KINETICS OF FLONASE

假设：吸入哮喘药物Flonase的生物分布和动力学将能够使用PET-MRI和PET-CT覆盖的新技术来表征。本研究的目的是定量评估氟替卡松在正常志愿者鼻腔内的生物分布，以及根据包装说明经鼻给药后时间的函数。本研究设计为单臂、开放式标签。PET扫描将以与先前开发并成功用于[11C]曲安奈德（NasacortAQ）研究相同的方式进行。在PET数据采集过程中，将对正常志愿者使用配制的放射性药物。氟替卡松是一种抗炎皮质类固醇，已被批准用于鼻吸入治疗过敏性鼻炎。它是一种鼻用喷雾剂，商品名为Flonase。自1993年以来，同一PET研究小组在大学医院进行了类似的研究。这些研究表明了PET成像吸入药物的可行性，以及PET- mri和PET- ct叠加技术产生相关解剖和动力学信息的有效性。这些研究中观察到的药物生物分布和动力学为先前研究的鼻吸入器（NasacortAQ）的长效特性提供了解释，建立了该药物的低全身吸收，发现了以前未知的生物分布方面，并为FDA对该药物的评估提供了有价值的信息。目前的研究建议进行基本相同的研究来调查氟替卡松。符合条件的受试者将被要求到大学医院核医学科的PET扫描仪前报告，在研究期间将在手臂上放置静脉导管进行血液采样。静脉导管将用于常规药代动力学取样。在给药后，患者将被安置在扫描场并进行长达4小时的动态成像。然后将受试者带到GCRC完成药代动力学采样和观察。这项研究已经完成。本研究已经完成。

Hypothesis: the biodistribution and kinetics of the inhaled asthma medication Flonase will be able to be characterized using the novel techniques of PET-MRI and PET-CT overlay. The objective of this study is to quantitatively evaluate the biodistribution of fluticasone in the nasal cavities of normal volunteers as a function of time following nasal administration according to package directions. The study design is single arm, and open label. PET scanning will be performed in the same fashion as was developed and successfully used for a previous study of [11C]triamcinolone acetonide (NasacortAQ). The formulated radio-pharmaceutical will be administered to normal volunteers during PET data acquisition. Fluticasone is an anti-inflammatory corticosteroid which has been approved for nasal inhalation for treatment of allergic rhinitis. It is marketed as a nasal spray under the trade name of Flonase. Previous studies similar to this proposed work have been performed at University Hospitals by this same PET research group since 1993. The studies have shown the feasibility of the PET imaging of inhaled drugs and the effectiveness of the technique of PET-MRI and PET-CT overlay to produce relevant anatomic and kinetic information. The drug biodistribution and kinetics observed in those studies provided an explanation for the long-acting properties of a previously studied nasal inhaler (NasacortAQ), established the low systemic absorption of that drug, discovered previously unknown aspects of the biodistribution, and provided valuable information for evaluation of the drug by the FDA. The current study proposes to carry out essentially the same study to investigate Fluticasone. Qualifying subjects will be asked to report to the PET scanner in the Division of Nuclear Medicine at University Hospitals where a venous catheter will be placed in an arm, for blood sampling during the study. The venous catheter will be used for conventional pharmacokinetic sampling. Immediately after dosing, patients will be positioned in the scan field and undergo dynamic imaging for up to four hours. Subjects will then be brought to the GCRC for completion of pharmacokinetic sampling and observation. The study has been completed. This study has been completed.