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

Hyperthyroidism Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02772705
• Other study ID #: 2016-92
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2016
• Last updated: May 11, 2016
• Start date: May 2016
• Est. completion date: January 2017

Study information

• Verified date: May 2016
• Source: West China Hospital
• Contact: Yahao Li, Bachelor
• Phone: +86 18080141841
• Email: 617381606[@]qq.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Sichuan Province
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Emission-Computed
• Graves Disease
• Hyperthyroidism
• Single-Photon
• Tomography

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing
China	West China Hospital	Chengdu	Sichuan
China	Guangzhou Panyu Central Hospital	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	The People's Hospital of Inner Mongolia Autonomous Region	Hohhot	Inner Mongolia
China	Hebei General Hospital	Shijiazhuang	Hebei
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Fourth Military Medical Universit	Xi'an	Shanxi
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (8)

Lead Sponsor	Collaborator
West China Hospital	Beijing Tongren Hospital, Fourth Military Medical University, Guangzhou Panyu Central Hospital, Hebei General Hospital, The First Affiliated Hospital of Zhengzhou University, Tianjin Medical University General Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The thyroid imaging of GD patients and normal humans by SPECT/CT	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	No
Primary	The SUV values of GD patients and normal humans provided by Q.Metrix	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	No