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

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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

Tracking Information
First Submitted Date May 9, 2016
First Posted Date May 13, 2016
Last Update Posted Date May 13, 2016
Study Start Date May 2016
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of SUV Using SPECT/CT Between Grave's Disease Patients and Normal Humans
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
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).
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Hyperthyroidism
  • Tomography
  • Emission-Computed
  • Single-Photon
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Bailey DL, Willowson KP. An evidence-based review of quantitative SPECT imaging and potential clinical applications. J Nucl Med. 2013 Jan;54(1):83-9. doi: 10.2967/jnumed.112.111476. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 11, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2017
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02772705
Other Study ID Numbers 2016-92
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
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

Responsible Party Li Yuhao, West China Hospital
Study Sponsor West China Hospital
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
Investigators
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
PRS Account West China Hospital
Verification Date May 2016