Clinical trial NCT02772705: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperthyroidism
Tomography
Emission-Computed
Single-Photon
Keywords: Standardized Uptake Value
Diagnosis
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tongren Hospital
name: Guangzhou Panyu Central Hospital
name: Hebei General Hospital
name: Air Force Military Medical University, China
name: Zhejiang Cancer Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Tianjin Medical University General Hospital
First posted: 2016-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: The thyroid imaging of GD patients and normal humans by SPECT/CT
timeFrame: a single point in time, at subject enrollment
measure: The SUV values of GD patients and normal humans provided by Q.Metrix
timeFrame: a single point in time, at subject enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Panyu Central Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Hohhot
country: China
facility: The People's Hospital of Inner Mongolia Autonomous Region
state: Inner Mongolia
city: Xi'an
country: China
facility: Fourth Military Medical Universit
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: West China Hospital of Sichuan University, Department of Nuclear Medicine
name: Lin Li, Master
role: STUDY_CHAIR
affiliation: West China Hospital of Sichuan University, Department of Nuclear Medicine
name: Xiaohong Ou, Ph.D
role: STUDY_DIRECTOR
affiliation: West China Hospital of Sichuan University, Department of Nuclear Medicine
name: Yahao Li, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.