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临床试验/NCT02237872
NCT02237872已完成不适用

Assessment of MRI Accuracy for the Detection of Brown Adipose Tissue Using [18F]-2-fluoro-2-deoxy-D-glucose (Fluorodeoxyglucose) -PET as a Gold Standard

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2015年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Average dice similarity coefficient

研究概览

简要总结

The primary goal of this study is to assess the accuracy of conventional fat fraction proton MRI for the detection of Brown Adipose Tissue (BAT) in healthy subjects using [18F]-2-fluoro-2-deoxy-D-glucose (fluorodeoxyglucose) -PET as gold standard.

In this pilot study, MRI and PET imaging of BAT of healthy adult volunteers will be performed on a combined PET/MRI scanner under mild cold condition.

详细描述

In the fight against obesity, brown adipose tissue (BAT) is considered to be the newest target. The hypothesis is that this tissue is partially responsible for the imbalance between energy intake and energy expenditure that keeps lean people lean and obese people obese.

The detection of this tissue in adult humans represents an unmet need. BAT is difficult to detect and measurements of tissue fat fraction performed by magnetic resonance imaging have been proposed as a mean to differentiate the highly hydrated brown fat from the less hydrated white adipose tissue and from muscle.

To this end, the objective of this study is to assess the accuracy of magnetic resonance fat fraction measurements for the detection of BAT volume in adult humans, while using PET with fluorodeoxyglucose as gold standard.

For this study subjects will undergo a combined MRI/PET scan. The scans will be done during stimulation of thermogenic activity by mild cold exposure.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Each subject must be fully informed and have signed consent.
  • BMI < 34
  • Normal neurological and psychological development / able to give consent
  • Willingness to participate in this study

排除标准

  • Subjects less than 18 years of age
  • Severe claustrophobia
  • Women who are pregnant, nursing an infant or planning to become pregnant in the next 30 days
  • People who have a condition that makes MRI unsafe for them (for example, cardiac pacemaker, epicardial pacemaker leads, cochlear implants, metal aneurysm clip, iron filings in your eyes or metal halo devices)
  • Have had radiation therapy or chemotherapy in the 2 months prior to PET scan
  • Subjects are taking medications that may interfere with BAT detection

结局指标

主要结局

Average dice similarity coefficient

时间窗: Up to 1 year after the imaging scan

The average dice similarity coefficient will be measured to assess the overlap between MRI and PET maps

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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