Thyroid NoduleNCT01757834
Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules
A study testing SWUS Elastography in people with Thyroid Nodule, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- SWUS Elastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of thyroid nodule
- Referred for thyroid FNA or surgery
Who cannot join
- Minors; age <18
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Thyroid Nodule
- Being tested
- SWUS Elastography
- Keywords
- Thyroid Nodule, Thyroid Neoplasm, Differential Diagnosis, Elastography, Elasticity Imaging Technique, Sonoelastography
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWUS ElastographyDevice
Also called Aixplorer Ultrasound System (SuperSonic Imagine, Inc)
| Study group | Role | What they receive |
|---|---|---|
| SWUS Elastography | Experimental | 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. Receives: Device: SWUS Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlating stiffness from the SWUS elastography with indentometer and pathology findings
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.
Measured: 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.
Secondary outcomes (1)
Correlating SWUS findings with routine US findings
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Manjiri Dighe, University of Washington
- Investigators
- Manjiri K. Dighe, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757834
- Sponsor's protocol ID
- 41443-EA
- Other IDs
- 1R21CA164112-01
- Status last verified
- May 2015
- First submitted
- 12 Dec 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17146329Rago 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.
PubMed 17535993Gharib 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.
PubMed 8420446Lyshchik 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.
PubMed 16118150Dighe 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.
PubMed 18539888Bae 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.
PubMed 17526611Utiger 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.
PubMed 15944422Hegedus L. Clinical practice. The thyroid nodule. N Engl J Med. 2004 Oct 21;351(17):1764-71. doi: 10.1056/NEJMcp031436. No abstract available.
PubMed 15496625Papini 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.
PubMed 11994321American 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.
PubMed 19860577Gharib 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.
PubMed 20543550Lyshchik 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.
PubMed 16231839Sebag 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.
PubMed 20881263Dighe 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.
PubMed 20375375Hong 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.
PubMed 19546328
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Shear Wave Ultrasound Elastography in Noninvasive Diagnosis of Thyroid Nodules
- ClinicalTrials.gov ID
- NCT01757834
- Acronym / sponsor ID
- 41443-EA
- Conditions
- Thyroid Nodule
- Keywords
- Thyroid Nodule, Thyroid Neoplasm, Differential Diagnosis, Elastography, Elasticity Imaging Technique, Sonoelastography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 31 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SWUS Elastography | Experimental | Device: SWUS ElastographyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of thyroid nodule
- Referred for thyroid FNA or surgery
Key exclusion criteria (2 listed)
- Minors; age <18
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SWUS ElastographyAlso: Aixplorer Ultrasound System (SuperSonic Imagine, Inc) | Device | SWUS Elastography |
Primary outcome
Correlating stiffness from the SWUS elastography with indentometer and pathology findings
Time frame: 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.
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.
1 secondary outcome
Correlating SWUS findings with routine US findings
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 17146329Frates 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.
- Background: PubMed 17535993Rago 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.
- Background: PubMed 8420446Gharib 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.
- Background: PubMed 16118150Lyshchik 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.
- Background: PubMed 18539888Dighe 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.
- Background: PubMed 17526611Bae 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.
- Background: PubMed 15944422Utiger 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.
- Background: PubMed 15496625Hegedus L. Clinical practice. The thyroid nodule. N Engl J Med. 2004 Oct 21;351(17):1764-71. doi: 10.1056/NEJMcp031436. No abstract available.
- Background: PubMed 11994321Papini 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.
- Background: PubMed 19860577American 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.
- Background: PubMed 20543550Gharib 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.
- Background: PubMed 16231839Lyshchik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manjiri K. Dighe, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SWUS Elastography in people with Thyroid Nodule, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlating stiffness from the SWUS elastography with indentometer and pathology findings (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01757834, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.