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

• Sponsor: West China Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02772705
• Collaborator: Beijing Tongren Hospital (Other), Guangzhou Panyu Central Hospital (Other), Hebei General Hospital (Other), Air Force Military Medical University, China (Other), Zhejiang Cancer Hospital (Other), The First Affiliated Hospital of Zhengzhou University (Other), Tianjin Medical University General Hospital (Other)
• Enrollment: 100
• Locations: 9
• Duration (Months): 8
• Patients Per Site: 11.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

• Study Type: Observational
• Anticipated 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 1, 2016
• Anticipated Primary Completion Date: Aug 1, 2016
• Anticipated Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. The thyroid imaging of GD patients and normal humans by SPECT/CT [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tongren Hospital	Beijing	Beijing	China	100000
2	Guangzhou Panyu Central Hospital	Guangzhou	Guangdong	China	510000
3	Hebei General Hospital	Shijiazhuang	Hebei	China	050000
4	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450000
5	The People's Hospital of Inner Mongolia Autonomous Region	Hohhot	Inner Mongolia	China	010000
6	Fourth Military Medical Universit	Xi'an	Shanxi	China	710000
7	West China Hospital	Chengdu	Sichuan	China	610000
8	Tianjin Medical University General Hospital	Tianjin	Tianjin	China	300000
9	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310000

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

• 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

Study Documents (Full-Text)

None provided.

More Information

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.

• 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
• Last Update Posted: May 13, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Li Yuhao, Technologist, a graduated student of Department of Nuclear Medicine, West China Hospital: Standardized Uptake Value; Diagnosis
• Additional relevant MeSH terms: Graves Disease; Hyperthyroidism

Study Results

No Results Posted as of May 13, 2016