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

May 11, 2016 updated by: Li Yuhao, West China Hospital

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

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).

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Beijing Tongren Hospital
        • Contact:
        • Principal Investigator:
          • Mei Li, PH.D
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Guangzhou Panyu Central Hospital
        • Principal Investigator:
          • Yi Huang
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • Hebei General Hospital
        • Contact:
        • Principal Investigator:
          • Yanzhu Bian, PH.D
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Principal Investigator:
          • Xingmin Han
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010000
        • Recruiting
        • The People's Hospital of Inner Mongolia Autonomous Region
        • Contact:
        • Principal Investigator:
          • Juzhen Liu
    • Shanxi
      • Xi'an, Shanxi, China, 710000
        • Recruiting
        • Fourth Military Medical Universit
        • Contact:
          • Guoquan Li, PH.D
          • Phone Number: +86 15809252822
          • Email: lgqby@sina.com
        • Principal Investigator:
          • Guoquan Li, PH.D
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital
        • Contact:
        • Principal Investigator:
          • Yahao Li, Bachelor
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
        • Principal Investigator:
          • Feng Dong, Master
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Linfa Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
a single point in time, 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.
a single point in time, at subject enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Collaborators

Zhejiang Cancer Hospital
Hebei General Hospital
Beijing Tongren Hospital
The First Affiliated Hospital of Zhengzhou University
Air Force Military Medical University, China
Tianjin Medical University General Hospital
Guangzhou Panyu Central 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 13, 2016

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-92

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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