Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-27 @ 1:28 AM
Study NCT ID:
NCT02772705
Status:
UNKNOWN
Last Update Posted:
2016-05-13
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of SUV Using SPECT/CT Between Grave's Disease Patients and Normal Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2016-05-09', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The thyroid imaging of GD patients and normal humans by SPECT/CT', 'timeFrame': 'a single point in time, at subject enrollment', 'description': '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.'}, {'measure': 'The SUV values of GD patients and normal humans provided by Q.Metrix', 'timeFrame': 'a single point in time, at subject enrollment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Standardized Uptake Value', 'Diagnosis'], 'conditions': ['Hyperthyroidism', 'Tomography', 'Emission-Computed', 'Single-Photon']}, 'referencesModule': {'references': [{'pmid': '23283563', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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).", 'detailedDescription': "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.\n\nOn 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.\n\nThis 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.\n\nAnd 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.\n\nEvery 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nFor the normal humans, they are healthy volunteers without thyroid disease.', 'healthyVolunteers': True, 'eligibilityCriteria': 'For Group of GD Patients:\n\nInclusion Criteria:\n\n* certainly diagnosed with GD\n* no treatment\n* sign a informed consent\n\nExclusion Criteria:\n\n* Inflammatory Hyperthyroidism\n* Secondary Hyperthyroidism (since of medicine, thyrotrophs neoplasms and etc)\n* Can not finish the check of SPECT/CT\n* Refuse to sign a informed consent\n\nFor Group of Normal Humans:\n\nInclusion Criteria:\n\n* without GD\n* Adult\n* sign a reformed consent\n\nExclusion Criteria:\n\n* Without normal values of TSH, FT3, FT4\n* Can not finish the check of SPECT/CT\n* Failed to sign a reformed consent'}, 'identificationModule': {'nctId': 'NCT02772705', 'briefTitle': "Comparison of SUV Using SPECT/CT Between Grave's Disease Patients and Normal Humans", 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': "Comparison of Standardized Update Value Using Single-photo Emission Computed Tomography and Computed Tomography Between Grave's Disease (Hyperthyroidism) Patients and Normal Humans", 'orgStudyIdInfo': {'id': '2016-92'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hyperthyroidism', 'description': "Those with Grave's Disease(GD,Hyperthyroidism),with lower TSH, and higher FT3, FT4."}, {'label': 'Health Humans', 'description': 'Those humans who are healthy, without GD, without any treatment, with normal TSH, FT3, FT4.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mei Li, PH.D', 'role': 'CONTACT', 'email': 'Lee_mei_bj@sina.com', 'phone': '+86 18811612193'}, {'name': 'Mei Li, PH.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Tongren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Huang', 'role': 'CONTACT', 'email': '13719231991@126.com', 'phone': '+86 13719231991'}, {'name': 'Yi Huang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangzhou Panyu Central Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanzhu Bian, PH.D', 'role': 'CONTACT', 'email': 'yanzhubian99@163.com', 'phone': '+86 13073129364'}, {'name': 'Yanzhu Bian, PH.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hebei General Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingmin Han', 'role': 'CONTACT', 'email': 'xmhan@zzu.edu.cn', 'phone': '+86 13838178090'}, {'name': 'Xingmin Han', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '010000', 'city': 'Hohhot', 'state': 'Inner Mongolia', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juzhen Liu', 'role': 'CONTACT', 'email': '1053525934@qq.com', 'phone': '+86 13604718831'}, {'name': 'Juzhen Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The People's Hospital of Inner Mongolia Autonomous Region", 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}, {'zip': '710000', 'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoquan Li, PH.D', 'role': 'CONTACT', 'email': 'lgqby@sina.com', 'phone': '+86 15809252822'}, {'name': 'Guoquan Li, PH.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fourth Military Medical Universit', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Li, Master', 'role': 'CONTACT', 'email': 'lilinhuaxi@sina.com', 'phone': '+86 13881833145'}, {'name': 'Yahao Li, Bachelor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300000', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Dong, Master', 'role': 'CONTACT', 'email': 'Dongfeng1105@sina.com', 'phone': '+86 13502116364'}, {'name': 'Feng Dong, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Linfa Li', 'role': 'CONTACT', 'email': 'pet-ct001@163.com', 'phone': '+86 13666670158'}, {'name': 'Linfa Li', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yahao Li, Bachelor', 'role': 'CONTACT', 'email': '617381606@qq.com', 'phone': '+86 18080141841'}, {'name': 'Lin Li, Master', 'role': 'CONTACT', 'email': 'lilinhuaxi@sina.com', 'phone': '+86 13881833145'}], 'overallOfficials': [{'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', 'affiliation': 'West China Hospital of Sichuan University, Department of Nuclear Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The data of the subjects will be shared including gender, age, values of SUV, TSH, FT3, FT4 and other relative records.\n\nThe information will not be shared until the study is completed and the article is published.\n\nAnyone who wants to get the data should send an e-mail to Li, with reasons for needing these data.\n\nE-mail address: 617381606@qq.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, {'name': 'Guangzhou Panyu Central Hospital', 'class': 'OTHER'}, {'name': 'Hebei General Hospital', 'class': 'OTHER'}, {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Technologist, a graduated student of Department of Nuclear Medicine', 'investigatorFullName': 'Li Yuhao', 'investigatorAffiliation': 'West China Hospital'}}}}