Non-Invasive Measurements of Brown Adipose Tissues

描述（由申请人提供）：在了解人类棕色脂肪组织[HBAT]的功能方面取得进展，并希望最终能够使用这种改进的理解来帮助控制当前的肥胖流行病，这将需要开发“能够测量人类群体中BAT的质量并测量HBAT的代谢活性的工具和方法”。拟议研究计划的目的是通过开发专为HBAT研究设计的用户友好，非侵入性和完全安全的微波辐射计来满足这些需求。辐射计将基于MMTC公司以前开发的手持式自校准数字辐射计。由NIH赞助。它们将被设计为能够在被动或主动模式下运行，可以分别测量HBAT的代谢活性和质量，并符合所有适用的FDA医疗器械安全标准。将向FDA提出申请，以获得这些辐射计的批准。将在组织等效体模中制造和测试具有固定和可变组织穿透深度的辐射计天线。将为各种体模配置和各种天线对加热的深层模拟六溴代丁基锡的测量辐射温度和位置进行编目，所有数据将以有助于解释六溴代丁基锡的被动和主动微波辐射测量的形式汇集。成功完成体模辐射计测试后，将在10名健康年轻志愿者身上测试双模辐射计，对他们进行FDG PET/CT扫描，以验证热/冷环境诱导的激活和非激活HBAT状态下放射性示踪剂的摄取。这些测试将在约翰霍普金斯大学医学院进行，由理查德L。Wahl，医学博士，F.A.C.R.，放射学和肿瘤学教授和亨利N。小瓦格纳核医学教授，他使用PET/CT扫描对HBAT进行了开创性的工作。这项工作的最终目标是用一种安全、更快、更便宜的微波辐射测量方法取代PET/CT的辐射和成本。只有用新方法直接比较人体受激和非受激HBAT状态下FDG的相对金标准，才能确定人体辐射测量的工作特性。 公共卫生相关性：该计划旨在开发一种医疗器械，旨在帮助医疗保健专业人员更好地了解人类棕色脂肪在对抗肥胖中的作用。这种更好的理解可以预期导致治疗肥胖症的方法的改进，目前肥胖症的流行是造成许多疾病和过早死亡的原因。

DESCRIPTION (provided by applicant): Progress in understanding the function of human brown adipose tissues [HBAT] and hopefully eventually being able to use this improved understanding to help control the current obesity epidemic will require the development of "tools and methods capable of measuring the mass of BAT in human populations and to measure metabolic activity of HBAT". The aim of the proposed research program is to meet these needs by developing user-friendly, non-invasive, and completely safe microwave radiometers specifically designed for HBAT research. The radiometers will be based on handheld, self-calibrating, digital radiometers developed previously by MMTC, Inc. under sponsorship of NIH. They will be designed to be capable of operating in either passive or active modes that can respectively measure the metabolic activity and mass of HBAT and meet all applicable FDA safety standards for medical devices. Application will be made to the FDA to obtain approval for these radiometers. Radiometer antennas with fixed and variable depth of penetration into tissues will be fabricated and tested in tissue equivalent phantoms. The measured radiometric temperatures and locations of heated deep-seated simulated HBAT will be cataloged for a variety of phantom configurations and various antennas and all data will be assembled in a form that aids in the interpretation of passive and active microwave radiometric measurements of HBAT. After successful completion of the testing of the radiometers in phantoms, the dual- mode radiometers will be tested on 10 healthy young volunteers on whom FDG PET/CT scans will be performed to verify uptake of the radioactive tracers in activated and non- activated HBAT states induced by hot/cold environments. The tests will be performed at Johns Hopkins University School of Medicine and supervised by Richard L. Wahl, M.D., F.A.C.R., Professor of Radiology and Oncology and Henry N. Wagner, Jr. Professor of Nuclear Medicine who has done pioneering work on HBAT using PET/CT scans. The ultimate goal of this work is to replace the radiation and cost of PET/CT with a safe, faster, and cheaper microwave radiometry method. Only by directly comparing the relative gold standard of FDG in the stimulated and non-stimulated HBAT states in humans with the new method can we determine the radiometry operating characteristics in man. PUBLIC HEALTH RELEVANCE: The proposed program is for the development of a medical device designed to aid healthcare professionals in gaining a better understanding of the role of human brown fat in fighting obesity. This better understanding can be expected to lead to improved methods for treating obesity, the current epidemic of obesity being responsible for many sicknesses and early deaths.