Nodular GoiterNCT01102127
Elastography in Thyroid Nodules
An observational study of Nodular Goiter and Thyroid Cancer, run by Castilla-León Health Service at 1 site in Spain.
Trial summary
Nodular goiter is a highly prevalent disease in iodine-deficient areas. Usually nodule assessment includes ultrasonography (US) and fine-needle aspiration (FNA), but some benign nodules can hardly be distinguished from carcinomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nodular Goiter, Thyroid Cancer
- What is being tested?
- Elastography
- Type of treatment
- Medical device
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2010to Sep 2010
- Phase
- Observational
- 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
Study population: General population with nodular goiter.
Who may be able to join
- Age > 18 yr.
- Recruitment in Endocrinology surgery.
- Nodular goiter.
- Multinodular goiter with dominant nodule > 1 cm.
Who cannot join
- Toxic nodules
- Non-accessible nodules to US or FNA
- Cystic nodules
- Nodules with calcifications in egg rind
- Contraindication of FNA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Ultrasound Elastastography in Thyroid Nodular Disease.
Nodular goiter is a highly prevalent disease in iodine-deficient areas. Usually nodule assessment includes ultrasonography (US) and fine-needle aspiration (FNA), but some benign nodules can hardly be distinguished from carcinomas. Elastography measures tissue elasticity using sonography, as malignancy is related to stiffness of solid organs. The investigators have designed a study to evaluate the diagnostic accuracy of elastography in nodular goiter. Consecutive patients will be assessed using US, FNA and elastography; the latter will be compared with cytology. Specificity, sensitivity, and predictive values will be calculated.
Read the detailed description
Aims:
Primary aim: to evaluate the diagnostic accuracy of elastography in thyroid nodules from a low-risk of thyroid cancer population.
Secondary aim: to evaluate the usefulness of elastography to detect carcinomas in thyroid nodules with indeterminate FNA.
Patient selection:
Inclusion criteria:
- Age > 18 yr.
- Recruitment in Endocrinology Clinics.
- Nodular goiter.
- Multinodular goiter with dominant nodule > 1 cm.
Exclusion criteria:
- Toxic nodules
- Non-accessible nodules to US or FNA
- Cystic nodules
- Nodules with calcifications in egg rind
- Contraindication for FNA
- Conditions
- Nodular Goiter, Thyroid Cancer
- Being tested
- Elastography
- Keywords
- elastography, thyroid nodule, fine-needle aspiration
- Medical subject headings
- Goiter, Nodular, Thyroid Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElastographyDevice
Performance of US, elastography and FNA.
| Study group | Role | What they receive |
|---|---|---|
| Goiter | Patients with nodular goiter Receives: Device: Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of elastography for thyroid cancer
Sensitivity, specifity, predictive values
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nodular GoiterStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Castilla-León Health Service
- Sponsor type
- University, hospital or other
- Investigators
- Alfonso Vidal-Casariego, MD, Principal investigator, Complejo Asistencial de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102127
- Sponsor's protocol ID
- TNUS122009
- Status last verified
- Apr 2011
- First submitted
- 12 Apr 2010
- Last updated
- 25 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20375375Tonacchera M, Pinchera A, Vitti P. Assessment of nodular goitre. Best Pract Res Clin Endocrinol Metab. 2010 Feb;24(1):51-61. doi: 10.1016/j.beem.2009.08.008.
PubMed 20172470Luo 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.
PubMed 19963828Friedrich-Rust M, Sperber A, Holzer K, Diener J, Grunwald F, Badenhoop K, Weber S, Kriener S, Herrmann E, Bechstein WO, Zeuzem S, Bojunga J. Real-time elastography and contrast-enhanced ultrasound for the assessment of thyroid nodules. Exp Clin Endocrinol Diabetes. 2010 Oct;118(9):602-9. doi: 10.1055/s-0029-1237701. Epub 2009 Oct 23.
PubMed 19856256Vidal-Casariego A, Lopez-Gonzalez L, Jimenez-Perez A, Ballesteros-Pomar MD, Kyriakos G, Urioste-Fondo A, Alvarez-San Martin R, Cano-Rodriguez I, Jimenez-Garcia de la Marina JM. Accuracy of ultrasound elastography in the diagnosis of thyroid cancer in a low-risk population. Exp Clin Endocrinol Diabetes. 2012 Nov;120(10):635-8. doi: 10.1055/s-0032-1323804. Epub 2012 Oct 16.
PubMed 23073921
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Ultrasound Elastastography in Thyroid Nodular Disease.
- ClinicalTrials.gov ID
- NCT01102127
- Acronym / sponsor ID
- TNUS122009
- Conditions
- Nodular Goiter, Thyroid Cancer
- Keywords
- elastography, thyroid nodule, fine-needle aspiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Castilla-León Health ServiceUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Apr 2010 (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.
Nodular goiter is a highly prevalent disease in iodine-deficient areas. Usually nodule assessment includes ultrasonography (US) and fine-needle aspiration (FNA), but some benign nodules can hardly be distinguished from carcinomas. Elastography measures tissue elasticity using sonography, as malignancy is related to stiffness of solid organs. The investigators have designed a study to evaluate the diagnostic accuracy of elastography in nodular goiter. Consecutive patients will be assessed using US, FNA and elastography; the latter will be compared with cytology. Specificity, sensitivity, and predictive values will be calculated.
Detailed description
Aims:
Primary aim: to evaluate the diagnostic accuracy of elastography in thyroid nodules from a low-risk of thyroid cancer population.
Secondary aim: to evaluate the usefulness of elastography to detect carcinomas in thyroid nodules with indeterminate FNA.
Patient selection:
Inclusion criteria:
- Age > 18 yr.
- Recruitment in Endocrinology Clinics.
- Nodular goiter.
- Multinodular goiter with dominant nodule > 1 cm.
Exclusion criteria:
- Toxic nodules
- Non-accessible nodules to US or FNA
- Cystic nodules
- Nodules with calcifications in egg rind
- Contraindication for FNA
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Goiter | – | Device: ElastographyPatients with nodular goiter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population with nodular goiter.
Key inclusion criteria (4 listed)
- Age > 18 yr.
- Recruitment in Endocrinology surgery.
- Nodular goiter.
- Multinodular goiter with dominant nodule > 1 cm.
Key exclusion criteria (5 listed)
- Toxic nodules
- Non-accessible nodules to US or FNA
- Cystic nodules
- Nodules with calcifications in egg rind
- Contraindication of FNA
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 |
|---|---|---|
| ElastographyPerformance of US, elastography and FNA. | Device | Goiter |
Primary outcome
Diagnostic accuracy of elastography for thyroid cancer
Time frame: 1 day
Sensitivity, specifity, predictive values
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2011.
- Background: PubMed 20375375Dighe 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.
- Background: PubMed 20172470Tonacchera M, Pinchera A, Vitti P. Assessment of nodular goitre. Best Pract Res Clin Endocrinol Metab. 2010 Feb;24(1):51-61. doi: 10.1016/j.beem.2009.08.008.
- Background: PubMed 19963828Luo 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.
- Background: PubMed 19856256Friedrich-Rust M, Sperber A, Holzer K, Diener J, Grunwald F, Badenhoop K, Weber S, Kriener S, Herrmann E, Bechstein WO, Zeuzem S, Bojunga J. Real-time elastography and contrast-enhanced ultrasound for the assessment of thyroid nodules. Exp Clin Endocrinol Diabetes. 2010 Oct;118(9):602-9. doi: 10.1055/s-0029-1237701. Epub 2009 Oct 23.
- Derived from this study: PubMed 23073921Vidal-Casariego A, Lopez-Gonzalez L, Jimenez-Perez A, Ballesteros-Pomar MD, Kyriakos G, Urioste-Fondo A, Alvarez-San Martin R, Cano-Rodriguez I, Jimenez-Garcia de la Marina JM. Accuracy of ultrasound elastography in the diagnosis of thyroid cancer in a low-risk population. Exp Clin Endocrinol Diabetes. 2012 Nov;120(10):635-8. doi: 10.1055/s-0032-1323804. Epub 2012 Oct 16.
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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.
Alfonso Vidal-Casariego, MD principal investigator
Complejo Asistencial de León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nodular Goiter and Thyroid Cancer, run by Castilla-León Health Service at 1 site in Spain.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 25 May 2011. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic accuracy of elastography for thyroid cancer (time frame: 1 day). 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 NCT01102127, which also lists 5 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 25 May 2011; AzTrials last refreshed its copy on 31 Oct 2026.