Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT02937467
Status:
AVAILABLE
Last Update Posted:
2016-10-18
First Post:
2016-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Multi-Center Study of Shear Wave Elastography on Thyroid Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016606', 'term': 'Thyroid Nodule'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'AVAILABLE', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-15', 'studyFirstSubmitDate': '2016-10-15', 'studyFirstSubmitQcDate': '2016-10-15', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['SWE', 'diagnosis'], 'conditions': ['Thyroid Nodules']}, 'referencesModule': {'references': [{'pmid': '22282182', 'type': 'BACKGROUND', 'citation': 'Berg WA, Cosgrove DO, Dore CJ, Schafer FK, Svensson WE, Hooley RJ, Ohlinger R, Mendelson EB, Balu-Maestro C, Locatelli M, Tourasse C, Cavanaugh BC, Juhan V, Stavros AT, Tardivon A, Gay J, Henry JP, Cohen-Bacrie C; BE1 Investigators. Shear-wave elastography improves the specificity of breast US: the BE1 multinational study of 939 masses. Radiology. 2012 Feb;262(2):435-49. doi: 10.1148/radiol.11110640.'}, {'pmid': '23623210', 'type': 'BACKGROUND', 'citation': 'Monpeyssen H, Tramalloni J, Poiree S, Helenon O, Correas JM. Elastography of the thyroid. Diagn Interv Imaging. 2013 May;94(5):535-44. doi: 10.1016/j.diii.2013.01.023. Epub 2013 Apr 25.'}, {'pmid': '24689885', 'type': 'BACKGROUND', 'citation': 'Xu JM, Xu XH, Xu HX, Zhang YF, Zhang J, Guo LH, Liu LN, Liu C, Zheng SG. Conventional US, US elasticity imaging, and acoustic radiation force impulse imaging for prediction of malignancy in thyroid nodules. Radiology. 2014 Aug;272(2):577-86. doi: 10.1148/radiol.14132438. Epub 2014 Apr 2.'}, {'pmid': '25533720', 'type': 'BACKGROUND', 'citation': 'Park AY, Son EJ, Han K, Youk JH, Kim JA, Park CS. Shear wave elastography of thyroid nodules for the prediction of malignancy in a large scale study. Eur J Radiol. 2015 Mar;84(3):407-412. doi: 10.1016/j.ejrad.2014.11.019. Epub 2014 Nov 27.'}, {'pmid': '25805059', 'type': 'RESULT', 'citation': 'Shiina T, Nightingale KR, Palmeri ML, Hall TJ, Bamber JC, Barr RG, Castera L, Choi BI, Chou YH, Cosgrove D, Dietrich CF, Ding H, Amy D, Farrokh A, Ferraioli G, Filice C, Friedrich-Rust M, Nakashima K, Schafer F, Sporea I, Suzuki S, Wilson S, Kudo M. WFUMB guidelines and recommendations for clinical use of ultrasound elastography: Part 1: basic principles and terminology. Ultrasound Med Biol. 2015 May;41(5):1126-47. doi: 10.1016/j.ultrasmedbio.2015.03.009. Epub 2015 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'The incidence rates of thyroid cancers have increased in the past decade. Additionally, up to 68% of people have thyroid nodules. Consequently, a precise evaluation of thyroid nodules is very important and can avoid unnecessary biopsy of benign nodules. Shear wave elastography(SWE), a novel ultrasound-based elastographic method, is a new real-time, quantitative, operator-independent, and reproducible technique. Briefly, shear wave elastography uses a radiation force produced by an ultrasonic beam to stress tissues and ultrafast sonographic tracking techniques to measure the speed of shear waves. Based on the Young modulus formula, tissue elasticity can be derived from the shear wave propagation speed, and a real-time color-coded elastogram can be displayed, showing softer tissue in blue and stiffer tissue in red.\n\nThere are lots of research confirmed that SWE has a certain value in the diagnosis of thyroid carcinoma. These studies include prospective studies and retrospective studies, but both belong to a single center study. It has not been applied to the study of the multicenter of thyroid disease.\n\nThe main purpose of the study is to assess the performance of SWE for identification of benign and malignant thyroid nodules and calculate the optimal cutoff value for each parameter in multicenter study; the secondary purpose is to evaluate the application value of SWE for uncertain nodules by FNA.', 'detailedDescription': 'SWE can prove the diagnostic performance in the differentiation of benign and malignant thyroid lesions\n\n1. Main purpose\n\n 1. to assess the performance of SWE for identification of benign and malignant thyroid nodules in multicenter study;\n 2. calculate the optimal cutoff value for each parameter in multicenter study\n2. Secondary purpose to evaluate the application value of SWE for uncertain nodules by FNA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. the size of the lesion is between 0.5～4cm\n2. the solid components in the lesion\\>50%；\n3. all patients perform FNA or surgery in one month after SWE examination\n\nExclusion Criteria:\n\n1. patients who are unwilling or unable to provide informed consent\n2. Woman who is pregnant or breastfeeding;\n3. Thyroid nodules with calcified which is beyond 1/2 diameter of lesion\n4. patients who have history of surgery、FNA or thermal ablation in ipsilateral thyroid\n5. patients who have serious cardiopulmonary diseases'}, 'identificationModule': {'nctId': 'NCT02937467', 'briefTitle': 'The Multi-Center Study of Shear Wave Elastography on Thyroid Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'Evaluation of Shear Wave Elastography in the Diagnosis and Management of Thyroid Nodules in Chinese Population: A Prospective, Multicenter Study', 'orgStudyIdInfo': {'id': 'SHSY-IEC-3.0/15-78/01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SWE', 'type': 'DEVICE', 'description': 'a novel ultrasound-based elastographic method, a new real-time, quantitative, operator-independent, and reproducible technique'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'liu wenying, Doctor', 'role': 'CONTACT', 'email': 'liuwy23@sina.com', 'phone': '86-10-88196941'}, {'name': 'liu boji, Doctor', 'role': 'CONTACT', 'email': 'jxjj1990@126.com', 'phone': '86-13641668014'}], 'overallOfficials': [{'name': 'yan kun, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}, {'name': 'xu huixiong, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai 10th People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'collaborators': [{'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief director', 'investigatorFullName': 'Kun Yan', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}