HyperthyroidismNCT02772705
Comparison of SUV Using SPECT/CT Between Grave's Disease Patients and Normal Humans
An observational study of Hyperthyroidism and Tomography, run by West China Hospital at 9 sites in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperthyroidism, Tomography, Emission-Computed
- How many people
- 100 participants
- Where
- 9 sitesChina
- Study dates
- May 2016to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- certainly diagnosed with GD
- no treatment
- sign a informed consent
- without GD
- Adult
- sign a reformed consent
Who cannot join
- 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:
- Without normal values of TSH, FT3, FT4
- Can not finish the check of SPECT/CT
- Failed to sign a reformed consent
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100000
Mei Li, PH.D, +86 18811612193, Lee_mei_bj@sina.com
Mei Li, PH.D
- Recruiting
West China Hospital
Chengdu, Sichuan, 610000
Lin Li, Master, +86 13881833145, lilinhuaxi@sina.com
Yahao Li, Bachelor
- Recruiting
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, 510000
Yi Huang, +86 13719231991, 13719231991@126.com
Yi Huang
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Linfa Li, +86 13666670158, pet-ct001@163.com
Linfa Li
- Recruiting
The People's Hospital of Inner Mongolia Autonomous Region
Hohhot, Inner Mongolia, 010000
Juzhen Liu, +86 13604718831, 1053525934@qq.com
Juzhen Liu
- Recruiting
Hebei General Hospital
Shijiazhuang, Hebei, 050000
Yanzhu Bian, PH.D, +86 13073129364, yanzhubian99@163.com
Yanzhu Bian, PH.D
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300000
Feng Dong, Master, +86 13502116364, Dongfeng1105@sina.com
Feng Dong, Master
- Recruiting
Fourth Military Medical Universit
Xi’an, Shanxi, 710000
Guoquan Li, PH.D, +86 15809252822, lgqby@sina.com
Guoquan Li, PH.D
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Xingmin Han, +86 13838178090, xmhan@zzu.edu.cn
Xingmin Han
About this study
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
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).
Read the 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.
- Conditions
- Hyperthyroidism, Tomography, Emission-Computed, Single-Photon
- Keywords
- Standardized Uptake Value, Diagnosis
- Medical subject headings
- Hyperthyroidism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: a single point in time, at subject enrollment
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.
Measured: a single point in time, at subject enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperthyroidismStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Li Yuhao, West China Hospital
- Investigators
- Lin Li, Master, Study chair, West China Hospital of Sichuan University, Department of Nuclear MedicineXiaohong Ou, Ph.D, Study director, West China Hospital of Sichuan University, Department of Nuclear MedicineYahao Li, Bachelor, Principal investigator, West China Hospital of Sichuan University, Department of Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772705
- Sponsor's protocol ID
- 2016-92
- Status last verified
- May 2016
- First submitted
- 9 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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
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.
PubMed 23283563
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02772705
- Acronym / sponsor ID
- 2016-92
- Conditions
- Hyperthyroidism, Tomography, Emission-Computed, Single-Photon
- Keywords
- Standardized Uptake Value, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- 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
- Study start
- May 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- certainly diagnosed with GD
- no treatment
- sign a informed consent
- without GD
- Adult
Key exclusion criteria (8 listed)
- 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
- Without normal values of TSH, FT3, FT4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 23283563Bailey 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Li, Master study chair
West China Hospital of Sichuan University, Department of Nuclear Medicine
Xiaohong Ou, Ph.D study director
West China Hospital of Sichuan University, Department of Nuclear Medicine
Yahao Li, Bachelor principal investigator
West China Hospital of Sichuan University, Department of Nuclear Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthyroidism and Tomography, run by West China Hospital at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yahao Li, Bachelor (+86 18080141841, 617381606@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The thyroid imaging of GD patients and normal humans by SPECT/CT (time frame: a single point in time, at subject enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02772705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.