NCT02772705

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

3 months

First QC Date

May 9, 2016

Last Update Submit

May 11, 2016

Conditions

Keywords

Standardized Uptake ValueDiagnosis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • certainly diagnosed with GD
  • no treatment
  • sign a informed consent

You may not qualify if:

  • 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 GD
  • Adult
  • sign a reformed consent
  • Without normal values of TSH, FT3, FT4
  • Can not finish the check of SPECT/CT
  • Failed to sign a reformed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Hebei General Hospital

Shijiazhuang, Hebei, 050000, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

The People's Hospital of Inner Mongolia Autonomous Region

Hohhot, Inner Mongolia, 010000, China

RECRUITING

Fourth Military Medical Universit

Xi’an, Shanxi, 710000, China

RECRUITING

West China Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related 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.

    PMID: 23283563BACKGROUND

MeSH Terms

Conditions

HyperthyroidismDisease

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lin Li, Master

    West China Hospital of Sichuan University, Department of Nuclear Medicine

    STUDY CHAIR
  • Xiaohong Ou, Ph.D

    West China Hospital of Sichuan University, Department of Nuclear Medicine

    STUDY DIRECTOR
  • Yahao Li, Bachelor

    West China Hospital of Sichuan University, Department of Nuclear Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yahao Li, Bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Technologist, a graduated student of Department of Nuclear Medicine

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 13, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

January 1, 2017

Last Updated

May 13, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

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

Locations