Non-Invasive Measurements of Brown Adipose Tissues

描述（由申请人提供）：了解人类棕色脂肪组织[HBAT]功能的进展，并希望最终能够利用这种改进的理解来帮助控制当前的肥胖流行，将需要开发“能够测量人类人群中BAT质量和测量HBAT代谢活动的工具和方法”。拟议研究计划的目的是通过开发专门为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。辐射计将基于手持式、自校准的数字辐射计，该辐射计先前由MMTC公司在NIH的赞助下开发。它们将被设计成能够在被动或主动模式下工作，可以分别测量HBAT的代谢活性和质量，并符合所有适用的FDA医疗设备安全标准。将向FDA提出申请，以获得这些辐射计的批准。具有固定和可变穿透深度的辐射计天线将被制造并在组织等效模型中进行测试。被加热的深层模拟HBAT的测量辐射温度和位置将根据各种模拟配置和各种天线进行编目，所有数据将以有助于解释HBAT的被动和主动微波辐射测量的形式进行汇总。在成功完成对幽灵辐射计的测试后，将对10名健康的年轻志愿者进行双模辐射计测试，对他们进行FDG PET/CT扫描，以验证在热/冷环境诱导的激活和非激活HBAT状态下对放射性示踪剂的吸收。测试将在约翰霍普金斯大学医学院进行，并由放射学和肿瘤学教授Richard L. Wahl, m.d., f.a.c.r.和核医学教授Henry N. Wagner, Jr.监督，他曾在利用PET/CT扫描进行HBAT的开创性工作。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。只有直接将人体受激和非受激HBAT状态下FDG的相对金标准与新方法进行比较，才能确定人体辐射测量的工作特性。

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.