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Comparison of SUV Using SPECT/CT Between Grave's Disease Patients and Normal Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02772705
Recruitment Status : Unknown
Verified May 2016 by Li Yuhao, West China Hospital.
Recruitment status was:  Recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Collaborators:
Beijing Tongren Hospital
Guangzhou Panyu Central Hospital
Hebei General Hospital
Air Force Military Medical University, China
Zhejiang Cancer Hospital
The First Affiliated Hospital of Zhengzhou University
Tianjin Medical University General Hospital
Information provided by (Responsible Party):
Li Yuhao, West China Hospital

Brief Summary:
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).

Condition or disease
Hyperthyroidism Tomography Emission-Computed Single-Photon

Detailed Description:

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.

The data of each participant will be gathered and stored. And the data processing will be done with the help of GE staff, using the software Q.Metrix to get the value of SUVmean, SUVmax. Finally T test will be used in comparison of the differences.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Comparison of Standardized Update Value Using Single-photo Emission Computed Tomography and Computed Tomography Between Grave's Disease (Hyperthyroidism) Patients and Normal Humans
Study Start Date : May 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperthyroidism

Group/Cohort
Hyperthyroidism
Those with Grave's Disease(GD,Hyperthyroidism),with lower TSH, and higher FT3, FT4.
Health Humans
Those humans who are healthy, without GD, without any treatment, with normal TSH, FT3, FT4.



Primary Outcome Measures :
  1. The thyroid imaging of GD patients and normal humans by SPECT/CT [ Time Frame: 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.

  2. The SUV values of GD patients and normal humans provided by Q.Metrix [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

As for GD patients, the study samples will be chosen from the patients in every medical center which participates in this study. And they will be chosen before their treatment.

For the normal humans, they are healthy volunteers without thyroid disease.

Criteria

For Group of GD Patients:

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Adult
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772705


Contacts
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Contact: Yahao Li, Bachelor +86 18080141841 617381606@qq.com
Contact: Lin Li, Master +86 13881833145 lilinhuaxi@sina.com

Locations
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China, Beijing
Beijing Tongren Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Mei Li, PH.D    +86 18811612193    Lee_mei_bj@sina.com   
Principal Investigator: Mei Li, PH.D         
China, Guangdong
Guangzhou Panyu Central Hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Yi Huang    +86 13719231991    13719231991@126.com   
Principal Investigator: Yi Huang         
China, Hebei
Hebei General Hospital Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Yanzhu Bian, PH.D    +86 13073129364    yanzhubian99@163.com   
Principal Investigator: Yanzhu Bian, PH.D         
China, Henan
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450000
Contact: Xingmin Han    +86 13838178090    xmhan@zzu.edu.cn   
Principal Investigator: Xingmin Han         
China, Inner Mongolia
The People's Hospital of Inner Mongolia Autonomous Region Recruiting
Hohhot, Inner Mongolia, China, 010000
Contact: Juzhen Liu    +86 13604718831    1053525934@qq.com   
Principal Investigator: Juzhen Liu         
China, Shanxi
Fourth Military Medical Universit Recruiting
Xi'an, Shanxi, China, 710000
Contact: Guoquan Li, PH.D    +86 15809252822    lgqby@sina.com   
Principal Investigator: Guoquan Li, PH.D         
China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610000
Contact: Lin Li, Master    +86 13881833145    lilinhuaxi@sina.com   
Principal Investigator: Yahao Li, Bachelor         
China, Tianjin
Tianjin Medical University General Hospital Recruiting
Tianjin, Tianjin, China, 300000
Contact: Feng Dong, Master    +86 13502116364    Dongfeng1105@sina.com   
Principal Investigator: Feng Dong, Master         
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Linfa Li    +86 13666670158    pet-ct001@163.com   
Principal Investigator: Linfa Li         
Sponsors and Collaborators
West China Hospital
Beijing Tongren Hospital
Guangzhou Panyu Central Hospital
Hebei General Hospital
Air Force Military Medical University, China
Zhejiang Cancer Hospital
The First Affiliated Hospital of Zhengzhou University
Tianjin Medical University General Hospital
Investigators
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Study Chair: Lin Li, Master West China Hospital of Sichuan University, Department of Nuclear Medicine
Study Director: Xiaohong Ou, Ph.D West China Hospital of Sichuan University, Department of Nuclear Medicine
Principal Investigator: Yahao Li, Bachelor West China Hospital of Sichuan University, Department of Nuclear Medicine
Publications:
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Responsible Party: Li Yuhao, Technologist, a graduated student of Department of Nuclear Medicine, West China Hospital
ClinicalTrials.gov Identifier: NCT02772705    
Other Study ID Numbers: 2016-92
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data of the subjects will be shared including gender, age, values of SUV, TSH, FT3, FT4 and other relative records.

The information will not be shared until the study is completed and the article is published.

Anyone who wants to get the data should send an e-mail to Li, with reasons for needing these data.

E-mail address: 617381606@qq.com

Keywords provided by Li Yuhao, West China Hospital:
Standardized Uptake Value
Diagnosis
Additional relevant MeSH terms:
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Graves Disease
Hyperthyroidism
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases