Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules
26. maj 2015 opdateret af: Manjiri Dighe, University of Washington
Efficacy of Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules
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.
Studieoversigt
Detaljeret beskrivelse
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.
In 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.
The 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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
175
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Washington
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Seattle, Washington, Forenede Stater, 98195
- University of Washington Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of thyroid nodule
- Referred for thyroid FNA or surgery
Exclusion Criteria:
- Minors; age <18
- Unable to provide informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: SWUS Elastography
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.
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Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Correlating stiffness from the SWUS elastography with indentometer and pathology findings
Tidsramme: 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.
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SWUS elastography can provide an objective score of stiffness, i.e., the Elasticity Index. Stiffness 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. |
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.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Correlating SWUS findings with routine US findings
Tidsramme: 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.
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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.
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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.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Manjiri K. Dighe, MD, University of Washington
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Thyroid. 2010 Aug;20(8):942. Hauger, Bryan R [corrected to Haugen, Bryan R]. Thyroid. 2010 Jun;20(6):674-5.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2012
Primær færdiggørelse (Forventet)
1. juli 2015
Studieafslutning (Forventet)
1. august 2015
Datoer for studieregistrering
Først indsendt
12. december 2012
Først indsendt, der opfyldte QC-kriterier
21. december 2012
Først opslået (Skøn)
31. december 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. maj 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. maj 2015
Sidst verificeret
1. maj 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 41443-EA
- 1R21CA164112-01 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Thyroid Nodule
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Premier G Med Cardio KftHungarian Ministry of Innovation and Technology; Semmelweis UniversityAfsluttetPapillar Thyroid MicrocarcinomUngarn
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Suez UniversityIkke rekrutterer endnu
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Minia UniversityAfsluttetGodartet Thyroid NoduleEgypten
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Xijing HospitalIkke rekrutterer endnuPapillar Thyroid MicrocarcinomKina
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University Hospital, GhentUniversitaire Ziekenhuizen KU Leuven; AZ Sint-Jan AVRekrutteringGodartet Thyroid NoduleBelgien
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Alpha Fusion Inc.RekrutteringDTC - Differentieret Thyroid CancerJapan
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Rigshospitalet, DenmarkUniversity of Copenhagen; Technical University of DenmarkRekruttering
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Hue University of Medicine and PharmacyDa Nang Family HospitalAktiv, ikke rekrutterendeGodartede Thyroid NodulesVietnam
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University of Sao Paulo General HospitalAktiv, ikke rekrutterende
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TheraclionAfsluttetGodartede Thyroid NodulesBulgarien
Kliniske forsøg med SWUS Elastography
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Beni-Suef UniversityRekrutteringNyrecortikal stivhed målt ved shear wave elastografi til evaluering af hydronefrose under graviditetGraviditet | HydronefroseEgypten
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Hospices Civils de LyonUkendtNyretransplantationFrankrig
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Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AfsluttetFedme | Fed leverForenede Stater
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Prof. Ziv Ben-Ari MDUkendt
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Sun Yat-sen UniversityAfsluttet
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Fifth Affiliated Hospital, Sun Yat-Sen UniversityRekrutteringLevercirrhose | LeverfibroseKina
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University of Wisconsin, MadisonNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) og andre samarbejdspartnereAktiv, ikke rekrutterendeIkke-alkoholisk fedtleversygdom | Ikke-alkoholisk SteatohepatitisForenede Stater
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Mayo ClinicNational Institute on Aging (NIA)Tilmelding efter invitationSund og rask | Alzheimers sygdom | Mild kognitiv svækkelseForenede Stater
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University of MichiganAfsluttet
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Instituto Ecuatoriano de Enfermedades DigestivasRekrutteringFibrose, lever | Lever SteatoseEcuador