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临床试验/NCT02772705
NCT02772705Unknown不适用

Comparison of Standardized Update Value Using Single-photo Emission Computed Tomography and Computed Tomography Between Grave's Disease (Hyperthyroidism) Patients and Normal Humans

West China Hospital9 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
9
主要终点
The SUV values of GD patients and normal humans provided by Q.Metrix

研究概览

简要总结

The purpose of this study is to find out the capacity of standardized uptake value (SUV) using single-photo emission computed tomography and computed tomography (SPECT/CT) in diagnosing Grave's Disease (hyperthyroidism).

详细描述

Traditionally it is considered that only positron emission tomography(PET) has the ability to obtain standardized uptake value(SUV)while single-photo emission computed tomography(SPECT) does not have. Recently with the developing of technology, the ability of SPECT has been extended.

On the other hand, thyroid imaging by SPECT can only play an auxiliary role in hyperthyroidism diagnosis mainly since it is regarded as nonquantitative. So the investigators design this study to search the capacity and accuracy of SUV provided by SPECT and CT(CT is used for reconstruction algorithm) in diagnosing GD.

This is a multiple-center study containing nine groups in China that use GE Discovery NM/CT, an advanced equipment. Thus, the data can be more accurate and more available.

And this is a perspective clinical trial, taking about eight months. The investigators plan to evaluate at least 50 Grave's Disease(GD) patients and 50 normal humans as contrast in all.

Every GD patient must have been diagnosed and the results of thyroid function tests(such as TSH,FT3,FT4) must be available. If necessary, the patient's rate of iodine uptake should also be known before he/she being included in this study. As for normal people, the results of thyroid function tests should be within the range of normal value.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • certainly diagnosed with GD
  • no treatment
  • sign a informed consent

排除标准

  • Inflammatory Hyperthyroidism
  • Secondary Hyperthyroidism (since of medicine, thyrotrophs neoplasms and etc)
  • Can not finish the check of SPECT/CT
  • Refuse to sign a informed consent
  • For Group of Normal Humans:
  • Inclusion Criteria:
  • without GD
  • sign a reformed consent
  • Exclusion Criteria:
  • Without normal values of TSH, FT3, FT4
  • Can not finish the check of SPECT/CT
  • Failed to sign a reformed consent

结局指标

主要结局

The SUV values of GD patients and normal humans provided by Q.Metrix

时间窗: a single point in time, at subject enrollment

The data of thyroid fusion imaging will be processed by the software, Q.Metrix, which can get the accurate SUV by compensating for photon absorption within the body, removing scattered radiation and etc.

The thyroid imaging of GD patients and normal humans by SPECT/CT

时间窗: a single point in time, at subject enrollment

For GD patients and normal healthy volunteers, we will get the data of thyroid fusion imaging by giving them a SPECT/CT check at subject enrollment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Li Yuhao

Technologist, a graduated student of Department of Nuclear Medicine

West China Hospital

研究点 (9)

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