Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 5:04 AM
Study NCT ID:
NCT06007859
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2023-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients Who Underwent Thyroid Ultrasonography at Our Institution Were Selected for Shear Wave Elastography of Thyroid Nodules, and the Maximum and Mean Values of the Modulus of Elasticity of the Nodules in Transverse and Longitudinal Sections Were Analyzed.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016606', 'term': 'Thyroid Nodule'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'elastic modulus values', 'timeFrame': 'The elastic modulus values of different sections were recorded immediately after the patients underwent routine ultrasound and shear wave elastography and the recorded results were saved.', 'description': 'the maximum value of elastic modulus (Emax) and the average value of elastic modulus (Emean) of benign and malignant nodules in both longitudinal and transverse sections'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Nodules']}, 'descriptionModule': {'briefSummary': 'The objective of this observational study was to evaluate the effect of transverse and longitudinal sections on the measurement of thyroid nodule stiffness by shear wave elastography. The main questions it aims to answer are: (i) to compare the diagnostic efficacy of different section orientations of shear wave elastography for the diagnosis of benign and malignant thyroid nodules; (ii) to analyze the correlation between the two orientations of transverse and longitudinal sections of shear wave elastography; and (iii) to compare the reliability and consistency of the two orientations of transverse and longitudinal sections of shear wave elastography for the diagnosis of thyroid nodules. Participants will undergo routine ultrasound examination of the thyroid gland and shear wave elastography, and the measured modulus of elasticity of the nodules in both transverse and longitudinal sections will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with thyroid nodules attending the First Affiliated Hospital of Shandong First Medical University were selected.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients underwent preoperative shear-wave elastography ultrasonography; thyroid nodules ranged from 3 to 20 mm in size; all nodules underwent puncture biopsy or surgery to obtain pathologic results.\n\nExclusion Criteria:\n\nUnavailability of pathology results for various reasons; poor quality of ultrasound images; missing data.'}, 'identificationModule': {'nctId': 'NCT06007859', 'acronym': 'SWE', 'briefTitle': 'Patients Who Underwent Thyroid Ultrasonography at Our Institution Were Selected for Shear Wave Elastography of Thyroid Nodules, and the Maximum and Mean Values of the Modulus of Elasticity of the Nodules in Transverse and Longitudinal Sections Were Analyzed.', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Influence of Section Orientation of Ultrasound Shear Wave Elastography on the Measurement of Thyroid Nodules Stiffness', 'orgStudyIdInfo': {'id': 'YXLL-KY-2023(024)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'section orientation of ultrasound shear wave elastography', 'interventionNames': ['Other: section orientation']}], 'interventions': [{'name': 'section orientation', 'type': 'OTHER', 'description': 'The patient was placed in a decubitus supine head back extension position to fully expose the cervical thyroid examination site. The instrument was adjusted appropriately to achieve optimal imaging quality, the suspicious nodule was located in conventional ultrasound mode, the SWE option in VT mode was selected, and the patient was instructed to hold his/her breath to minimize the effect of respiration, and elastograms of the nodule in transverse and longitudinal sections were obtained.', 'armGroupLabels': ['section orientation of ultrasound shear wave elastography']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shandong', 'country': 'China', 'facility': 'QianfoshanH', 'geoPoint': {'lat': 40.28464, 'lon': 120.48412}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Lack of resources or infrastructure: Sharing IPDs requires resources and infrastructure to ensure data security, manage access requests and provide necessary documentation. Currently these resources are not well developed, so it may be difficult to share IPDs.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ma Zhe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Ultrasound', 'investigatorFullName': 'Ma Zhe', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}