Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT03307694
Status:
COMPLETED
Last Update Posted:
2019-12-03
First Post:
2017-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thyroid Ultrasound Elasticity (TrUE) Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D016606', 'term': 'Thyroid Nodule'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-01', 'studyFirstSubmitDate': '2017-10-03', 'studyFirstSubmitQcDate': '2017-10-06', 'lastUpdatePostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of Malignancy by SWEI Imaging', 'timeFrame': 'Pre-operative visit (within 24 hours before surgery, on average)', 'description': 'As part of the pre-operative visit, participants will have imaging of their thyroid nodules. Established SWEI and MAC-SWEI techniques will be performed to identify malignant thyroid tissue.'}, {'measure': 'Determination of Malignancy by Pathological Proof', 'timeFrame': 'Post-surgery (within 10 days after surgery, on average)', 'description': "Tissue samples obtained during the participant's thyroid biopsy, thyroidectomy, or cervical node biopsy will be submitted to the pathology lab as part of the clinical standard of care. The pathology report will specify whether or not malignant cells were found in the tissue sample."}], 'secondaryOutcomes': [{'measure': 'Accuracy of differentiating benign from malignant lesions between SWEI techniques', 'timeFrame': 'Pre-operative visit (within 24 hours before surgery, on average)', 'description': 'The ability of MAC-SWEI to differentiate benign from malignant lesions will be compared to the ability of standard SWEI to make this differentiation.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cancer', 'Thyroid nodule', 'Imaging', 'Radiology'], 'conditions': ['Cancer, Thyroid']}, 'descriptionModule': {'briefSummary': 'In this study the researchers will scan the thyroid nodules of patients scheduled for surgical removal of these nodules. During their preadmission testing, but prior to their surgery, the researchers will perform standard ultrasound and shear wave elasticity imaging (SWEI) scans of the thyroid nodules in these patients. Both images can be generated by the same ultrasound scanner and within the same imaging session without having to switch out any equipment. The results of the SWEI scans will be compared to the definitive diagnosis from pathology obtained after pathologists have examined the removed nodules post-operatively.', 'detailedDescription': 'Thyroid ultrasound is a first-line procedure to assess patients with thyroid nodules. Unfortunately, standard ultrasound has low sensitivity, and thus low positive predictive value, for malignancy and many patients with thyroid nodules are referred for additional imaging studies or biopsy. Shear wave elasticity imaging (SWEI) is a non-invasive ultrasound technology that allows clinicians to assess the stiffness of tissues. In many solid tumors, increased stiffness is highly specific for underlying malignancy, and preliminary studies have shown this to be true for thyroid malignancies. Both standard sonography and SWEI can be performed on the same ultrasound equipment and within the same imaging session. Therefore, integrating SWEI into standard thyroid diagnostic workflow is a logical approach towards improving the positive predictive value of these first-line sonographic studies. Other studies have demonstrated the ability of SWEI techniques to differentiate benign from malignant thyroid nodules. However, shear wave techniques still need to overcome challenges before they can be successfully integrated into the clinical paradigm. These techniques still struggle to accurately classify follicular carcinomas and few have been validated in patients with multiple thyroid lesions, a scenario which is clinically common. The researchers believe that a multi-angle compound SWEI (MAC-SWEI) algorithm, which generates shear images based on multiple angled push beams, has the potential to generate more accurate shear wave images in the context of thyroid imaging. To this end, this study will perform proof-of-concept studies of MAC-SWEI in thyroid patients undergoing standard ultrasound scans and compare the results of shear wave images to results from corresponding pathology.\n\nStudy participants will undergo a single SWEI session within their normally-scheduled preadmission testing during which both standard b-mode and shear images of the thyroid nodule(s) will be acquired. The 36 patients will be randomized to receive MAC-SWEI, standard SWEI, and ultrasound, or only standard SWEI and ultrasound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will be recruited from patients of the Emory Healthcare system who are scheduled to have a thyroid biopsy, thyroidectomy, or cervical node biopsy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Scheduled to undergo a thyroid biopsy, thyroidectomy, or cervical node biopsy\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03307694', 'briefTitle': 'Thyroid Ultrasound Elasticity (TrUE) Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Multi-Angle Compound Shear Wave Elasticity Imaging for the Characterization of Thyroid Nodules', 'orgStudyIdInfo': {'id': 'IRB00092785'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MAC-SWEI, standard SWEI, ultrasound', 'description': 'Participants in this group will receive all three imaging techniques', 'interventionNames': ['Diagnostic Test: Ultrasound', 'Diagnostic Test: Shear wave elasticity imaging', 'Diagnostic Test: Multi-angle compound shear wave elasticity imaging']}, {'label': 'Standard SWEI, ultrasound', 'description': 'Participants in this group will receive two imaging techniques', 'interventionNames': ['Diagnostic Test: Ultrasound', 'Diagnostic Test: Shear wave elasticity imaging']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'All ultrasound images will be acquired by an in-house ultrasound technologist using a Verasonics Vantage (Verasonics Inc., Kirkland, Washington, USA) ultrasound system. During imaging, the technologist will position the Verasonics transducer, under b-mode guidance, in planes overlying the thyroid nodules approximating those obtained during previous clinical ultrasound scans.', 'armGroupLabels': ['MAC-SWEI, standard SWEI, ultrasound', 'Standard SWEI, ultrasound']}, {'name': 'Shear wave elasticity imaging', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['SWEI'], 'description': 'Shear wave elasticity imaging (SWEI) is obtained during the standard ultrasound session. The generation of shear wave images consists of two important steps called "pushing" and "tracking". First, in the "pushing" mode, a long focused ultrasound beam is transmitted to perturb tissue, generating ultrasonic shear waves in tissue that propagate perpendicular to the direction of pushing. In the "tracking" mode, shear wave propagation is observed and recorded. Because the speed of shear waves is a function of Young\'s modulus, these data reveal information about the stiffness of underlying biological tissue.', 'armGroupLabels': ['MAC-SWEI, standard SWEI, ultrasound', 'Standard SWEI, ultrasound']}, {'name': 'Multi-angle compound shear wave elasticity imaging', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['MAC-SWEI'], 'description': "The multi-angle compound SWEI (MAC-SWEI) algorithm, which generates shear images based on multiple angled push beams, has the potential to generate more accurate shear wave images in the context of thyroid imaging. To assess the MAC-SWEI technique, shear wave images will be used to generate estimates of the relative stiffness of lesions via their normalized Young's modulus.", 'armGroupLabels': ['MAC-SWEI, standard SWEI, ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Univeristy Hospital Midtown', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Stanislav Emelianov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Professor', 'investigatorFullName': 'Stanislav Emelianov', 'investigatorAffiliation': 'Emory University'}}}}