Clinical trial · Interventional
Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules
Efficacy of Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules
NCT01757834CI-TRIAL-00018071unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SWUS Elastography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (1)
- measure
- Correlating stiffness from the SWUS elastography with indentometer and pathology 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of thyroid nodule * Referred for thyroid FNA or surgery Exclusion Criteria: * Minors; age \<18 * Unable to provide informed consent
References
Publications (22)
- BACKGROUNDFrates 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 17146329
- BACKGROUNDRago 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 17535993
- BACKGROUNDGharib 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 8420446
- BACKGROUNDLyshchik 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 16118150
- BACKGROUNDDighe 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 18539888
- BACKGROUNDBae 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 17526611
- BACKGROUNDUtiger 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.