Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-08 @ 8:19 AM
Study NCT ID:
NCT01757834
Status:
UNKNOWN
Last Update Posted:
2015-05-28
First Post:
2012-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules
Sponsor:
Organization:
Raw JSON
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A one-time SWUS elastography will be performed on Day 1 within 2 months prior to the patients scheduled clinical FNA or surgery.', 'description': 'SWUS elastography can provide an objective score of stiffness, i.e., the Elasticity Index.\n\nStiffness from the SWUS elastography will be correlated with the elasticity measured with an indentometer to validate the Elasticity Index. The Elasticity Index will also be correlated with the histopathologic diagnosis. The sensitivity and specificity of the method for the diagnosis of malignancy will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Correlating SWUS findings with routine US findings', 'timeFrame': 'Up to 2 months. A one-time SWUS elastography will be performed on Day 1 within 2 months prior to the patients scheduled clinical FNA or surgery.', 'description': 'The investigators will compare the SWUS findings to the routine US findings. This will help us develop criteria based on combined findings to decide if a thyroid nodule is suspicious enough to warrant a FNA biopsy. These criteria can then be used for future prospective studies.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thyroid Nodule', 'Thyroid Neoplasm', 'Differential Diagnosis', 'Elastography', 'Elasticity Imaging Technique', 'Sonoelastography'], 'conditions': ['Thyroid Nodule']}, 'referencesModule': {'references': [{'pmid': '17146329', 'type': 'BACKGROUND', 'citation': 'Frates MC, Benson CB, Charboneau JW, Cibas ES, Clark OH, Coleman BG, Cronan JJ, Doubilet PM, Evans DB, Goellner JR, Hay ID, Hertzberg BS, Intenzo CM, Jeffrey RB, Langer JE, Larsen PR, Mandel SJ, Middleton WD, Reading CC, Sherman SI, Tessler FN. Management of thyroid nodules detected at US: Society of Radiologists in Ultrasound consensus conference statement. Ultrasound Q. 2006 Dec;22(4):231-8; discussion 239-40. doi: 10.1097/01.ruq.0000226877.19937.a1.'}, {'pmid': '17535993', 'type': 'BACKGROUND', 'citation': 'Rago T, Santini F, Scutari M, Pinchera A, Vitti P. Elastography: new developments in ultrasound for predicting malignancy in thyroid nodules. J Clin Endocrinol Metab. 2007 Aug;92(8):2917-22. doi: 10.1210/jc.2007-0641. Epub 2007 May 29.'}, {'pmid': '8420446', 'type': 'BACKGROUND', 'citation': 'Gharib H, Goellner JR. Fine-needle aspiration biopsy of the thyroid: an appraisal. Ann Intern Med. 1993 Feb 15;118(4):282-9. doi: 10.7326/0003-4819-118-4-199302150-00007.'}, {'pmid': '16118150', 'type': 'BACKGROUND', 'citation': 'Lyshchik A, Higashi T, Asato R, Tanaka S, Ito J, Mai JJ, Pellot-Barakat C, Insana MF, Brill AB, Saga T, Hiraoka M, Togashi K. Thyroid gland tumor diagnosis at US elastography. Radiology. 2005 Oct;237(1):202-11. doi: 10.1148/radiol.2363041248. Epub 2005 Aug 18.'}, {'pmid': '18539888', 'type': 'BACKGROUND', 'citation': 'Dighe M, Bae U, Richardson ML, Dubinsky TJ, Minoshima S, Kim Y. Differential diagnosis of thyroid nodules with US elastography using carotid artery pulsation. Radiology. 2008 Aug;248(2):662-9. doi: 10.1148/radiol.2482071758. Epub 2008 Jun 6.'}, {'pmid': '17526611', 'type': 'BACKGROUND', 'citation': 'Bae U, Dighe M, Dubinsky T, Minoshima S, Shamdasani V, Kim Y. Ultrasound thyroid elastography using carotid artery pulsation: preliminary study. J Ultrasound Med. 2007 Jun;26(6):797-805. doi: 10.7863/jum.2007.26.6.797.'}, {'pmid': '15944422', 'type': 'BACKGROUND', 'citation': 'Utiger RD. The multiplicity of thyroid nodules and carcinomas. N Engl J Med. 2005 Jun 9;352(23):2376-8. doi: 10.1056/NEJMp058061. No abstract available.'}, {'pmid': '15496625', 'type': 'BACKGROUND', 'citation': 'Hegedus L. Clinical practice. The thyroid nodule. N Engl J Med. 2004 Oct 21;351(17):1764-71. doi: 10.1056/NEJMcp031436. No abstract available.'}, {'pmid': '11994321', 'type': 'BACKGROUND', 'citation': 'Papini E, Guglielmi R, Bianchini A, Crescenzi A, Taccogna S, Nardi F, Panunzi C, Rinaldi R, Toscano V, Pacella CM. Risk of malignancy in nonpalpable thyroid nodules: predictive value of ultrasound and color-Doppler features. J Clin Endocrinol Metab. 2002 May;87(5):1941-6. doi: 10.1210/jcem.87.5.8504.'}, {'pmid': '19860577', 'type': 'BACKGROUND', 'citation': 'American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer; Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, Mazzaferri EL, McIver B, Pacini F, Schlumberger M, Sherman SI, Steward DL, Tuttle RM. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009 Nov;19(11):1167-214. doi: 10.1089/thy.2009.0110.'}, {'pmid': '20543550', 'type': 'BACKGROUND', 'citation': 'Gharib H, Papini E, Paschke R, Duick DS, Valcavi R, Hegedus L, Vitti P; AACE/AME/ETA Task Force on Thyroid Nodules. American Association of Clinical Endocrinologists, Associazione Medici Endocrinologi, and European Thyroid Association medical guidelines for clinical practice for the diagnosis and management of thyroid nodules. J Endocrinol Invest. 2010;33(5 Suppl):1-50.'}, {'pmid': '16231839', 'type': 'BACKGROUND', 'citation': 'Lyshchik A, Higashi T, Asato R, Tanaka S, Ito J, Hiraoka M, Brill AB, Saga T, Togashi K. Elastic moduli of thyroid tissues under compression. Ultrason Imaging. 2005 Apr;27(2):101-10. doi: 10.1177/016173460502700204.'}, {'pmid': '20881263', 'type': 'BACKGROUND', 'citation': 'Sebag F, Vaillant-Lombard J, Berbis J, Griset V, Henry JF, Petit P, Oliver C. Shear wave elastography: a new ultrasound imaging mode for the differential diagnosis of benign and malignant thyroid nodules. J Clin Endocrinol Metab. 2010 Dec;95(12):5281-8. doi: 10.1210/jc.2010-0766. Epub 2010 Sep 29.'}, {'pmid': '20375375', 'type': 'BACKGROUND', 'citation': 'Dighe M, Kim J, Luo S, Kim Y. Utility of the ultrasound elastographic systolic thyroid stiffness index in reducing fine-needle aspirations. J Ultrasound Med. 2010 Apr;29(4):565-74. doi: 10.7863/jum.2010.29.4.565.'}, {'pmid': '19546328', 'type': 'BACKGROUND', 'citation': 'Hong Y, Liu X, Li Z, Zhang X, Chen M, Luo Z. Real-time ultrasound elastography in the differential diagnosis of benign and malignant thyroid nodules. J Ultrasound Med. 2009 Jul;28(7):861-7. doi: 10.7863/jum.2009.28.7.861.'}, {'pmid': '18288024', 'type': 'BACKGROUND', 'citation': 'Tranquart F, Bleuzen A, Pierre-Renoult P, Chabrolle C, Sam Giao M, Lecomte P. [Elastosonography of thyroid lesions]. J Radiol. 2008 Jan;89(1 Pt 1):35-9. doi: 10.1016/s0221-0363(08)70367-6. French.'}, {'pmid': '19963828', 'type': 'BACKGROUND', 'citation': 'Luo S, Kim EH, Dighe M, Kim Y. Screening of thyroid nodules by ultrasound elastography using diastolic strain variation. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:4420-3. doi: 10.1109/IEMBS.2009.5332744.'}, {'pmid': '16484352', 'type': 'BACKGROUND', 'citation': 'Itoh A, Ueno E, Tohno E, Kamma H, Takahashi H, Shiina T, Yamakawa M, Matsumura T. Breast disease: clinical application of US elastography for diagnosis. Radiology. 2006 May;239(2):341-50. doi: 10.1148/radiol.2391041676. Epub 2006 Feb 16.'}, {'pmid': '21163507', 'type': 'BACKGROUND', 'citation': 'Luo S, Kim EH, Dighe M, Kim Y. Thyroid nodule classification using ultrasound elastography via linear discriminant analysis. Ultrasonics. 2011 May;51(4):425-31. doi: 10.1016/j.ultras.2010.11.008. Epub 2010 Nov 27.'}, {'pmid': '9664648', 'type': 'BACKGROUND', 'citation': "Erkamp RQ, Wiggins P, Skovoroda AR, Emelianov SY, O'Donnell M. Measuring the elastic modulus of small tissue samples. Ultrason Imaging. 1998 Jan;20(1):17-28. doi: 10.1177/016173469802000102."}, {'pmid': '2194336', 'type': 'BACKGROUND', 'citation': 'Parker KJ, Huang SR, Musulin RA, Lerner RM. Tissue response to mechanical vibrations for "sonoelasticity imaging". Ultrasound Med Biol. 1990;16(3):241-6. doi: 10.1016/0301-5629(90)90003-u.'}, {'pmid': '15498910', 'type': 'BACKGROUND', 'citation': 'Iannuccilli JD, Cronan JJ, Monchik JM. Risk for malignancy of thyroid nodules as assessed by sonographic criteria: the need for biopsy. J Ultrasound Med. 2004 Nov;23(11):1455-64. doi: 10.7863/jum.2004.23.11.1455.'}]}, 'descriptionModule': {'briefSummary': 'Shear wave ultrasound elastography is a new technique of finding the softness or hardness in tissue by applying a "push" generated by the machine. This technique will help in diagnosing malignancy in the thyroid gland without biopsy and avoiding biopsy in noncancerous nodules.', 'detailedDescription': 'Thyroid nodules are a common medical problem. With the wide use of various imaging modalities, incidentally detected thyroid nodules are becoming more common. However most of these nodules are benign with only a small proportion of 5-10% being malignant. With the increasing number of nodules detected, evaluation of these thyroid nodules presents a diagnostic challenge since the imaging modality used for evaluation at present, i.e., ultrasound (US) alone, has a low specificity of approximately 50-70%. In order to improve specificity to confidently diagnose malignancy in the thyroid nodule, a fine needle aspiration (FNA) biopsy is performed.\n\nIn recent years, US elastography has been shown to have high specificity of 90- 98% in various studies in differentiating between benign and malignant nodules. US elastography works on the principle of detecting the stiffness within a tissue by applying compression which can be manual compression or by generation of a remote radiation force by focused ultrasonic beams called as shear waves. Shear Wave Ultrasound (SWUS) elastography is an objective method of US elastography that detects the stiffness within the nodule since the strength of the shear wave generated is known and can be controlled. SWUS elastography has shown promise in being able to noninvasively diagnose papillary carcinoma in previous studies involving preoperative patients.\n\nThe investigators propose to perform a study to investigate the efficacy of SWUS elastography in diagnosing malignant thyroid nodules and noninvasively decreasing the number of FNAs performed by avoiding FNA in benign nodules. The Investigators will enroll patients with thyroid nodules before they undergo FNA biopsy or surgery. We also propose to compare routine US and SWUS elastography and their combined use in differentiating malignant from benign nodules. The investigators hypothesize that SWUS elastography can be used as a noninvasive screening tool, prior to an FNA, to screen out benign and malignant nodules with high level of confidence and reduce the number of biopsies in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of thyroid nodule\n* Referred for thyroid FNA or surgery\n\nExclusion Criteria:\n\n* Minors; age \\<18\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01757834', 'briefTitle': 'Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Efficacy of Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules', 'orgStudyIdInfo': {'id': '41443-EA'}, 'secondaryIdInfos': [{'id': '1R21CA164112-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21CA164112-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SWUS Elastography', 'description': 'This is a noninvasive technique using focused ultrasonic beams (pushing beams.) Several pushing beams at increasing depths are transmitted to generate a quasi-plane shear wave frame that propagates throughout the imaging area. After generating the shear wave, an ultrafast imaging sequence is performed to acquire successive raw radiofrequency dots at a very high frame rate (up to 20,000 per second). A tissue elasticity assessment can be derived from shear wave propagation speed. A color-coded image is displayed; softer tissue in blue and stiffer tissue in red. Quantitative information is delivered by drawing regions of interest on the thyroid and surrounding tissues which is the Elasticity Index expressed in kilo-Pascal (kPa). Due to the lack of manual compression and known value of the strength of pushing beam, SWUS gives an objective number to stiffness within the nodule.', 'interventionNames': ['Device: SWUS Elastography']}], 'interventions': [{'name': 'SWUS Elastography', 'type': 'DEVICE', 'otherNames': ['Aixplorer Ultrasound System (SuperSonic Imagine, Inc)'], 'armGroupLabels': ['SWUS Elastography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Manjiri K. Dighe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Radiology', 'investigatorFullName': 'Manjiri Dighe', 'investigatorAffiliation': 'University of Washington'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-04-28', 'type': 'RELEASE'}, {'date': '2018-05-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Manjiri Dighe, Associate Professor of Radiology, University of Washington'}}}}