ElastographyElastographyNCT02462512
Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer
An observational study of Elastography and Thyroid Nodule, run by Dong Jun Lim at 1 site in South Korea.
Trial summary
For patients with thyroid gland nodule, fine-needle aspiration biopsy has been proved to be an efficient tool for thyroid cancer diagnosis. However, it is somewhat an invasive procedure and is subject to sampling and analysis uncertainties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elastography, Thyroid Nodule
- How many people
- 590 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Aug 2017
- 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: The patients with thyroid nodule who visit tertiary hospital for fine needle aspiration biopsy
Who may be able to join
- The patients with thyroid nodule who are supposed to take fine needle aspiration biopsy
Who cannot join
- The patients who do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St Mary's Hospital
Seocho-gu, Seoul, 137-701
Dong Jun Lim, Dr., +82-2-2258-6009, ldj6026@catholic.ac.kr
Kwanhoon Jo, Dr., 82-2-2258-6340, lovi@naver.com
About this study
Official title: Validation of Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer
For patients with thyroid gland nodule, fine-needle aspiration biopsy has been proved to be an efficient tool for thyroid cancer diagnosis. However, it is somewhat an invasive procedure and is subject to sampling and analysis uncertainties. Thus, improved, more reliable criteria for determining which nodule should be be aspirated are needed. Ultrasound elastography has been shown to be useful in the differential diagnosis of breast and prostate cancers. Ultrasound elastography also may discriminate malignant from benign nodule.
Read the detailed description
To prospectively evaluate the elastographic appearance of thyroid cancer and explore the potential sensitivity and specificity of elastography for differentiating benign and malignant tumors, with histopathologic analysis as the reference standard.
- Conditions
- Elastography, Thyroid Nodule
- Keywords
- Elastography, Thyroid nodule
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FNAB of Thyroid nodule | The Patients with thyroid nodule who are scheduled for FNAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of elastography using in-vivo compression for detection of thyroid cancer
Measuring ECI(Elasticity contrast index) of thyroid nodule by ultrasound elastography
Measured: 1 year
Secondary outcomes (1)
Determination of the parameters which could have influence on the diagnostic performance of ultrasound elastography using in-vivo compression
Analysis of clinical characteristics of thyroid nodules and patients which are related to the diagnostic performance of ultrasound elastography
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ElastographyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Jun Lim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Jun Lim, Seoul St. Mary's Hospital
- Investigators
- Dong Jun Lim, Dr., Principal investigator, Associate Professor, Head, Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of KoreaMin Hee Kim, Dr., Study director, Clinical Assistant Professor, Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462512
- Sponsor's protocol ID
- SeoulStMary
- Acronym
- Elastography
- Status last verified
- Oct 2016
- First submitted
- 20 Apr 2015
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18539888Luo S, Lim DJ, Kim Y. Objective ultrasound elastography scoring of thyroid nodules using spatiotemporal strain information. Med Phys. 2012 Mar;39(3):1182-9. doi: 10.1118/1.3679857.
PubMed 22380349Lim DJ, Luo S, Kim MH, Ko SH, Kim Y. Interobserver agreement and intraobserver reproducibility in thyroid ultrasound elastography. AJR Am J Roentgenol. 2012 Apr;198(4):896-901. doi: 10.2214/AJR.11.7009.
PubMed 22451558
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer
- ClinicalTrials.gov ID
- NCT02462512
- Acronym / sponsor ID
- Elastography / SeoulStMary
- Conditions
- Elastography, Thyroid Nodule
- Keywords
- Elastography, Thyroid nodule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Dong Jun LimUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2017 (estimated)
- First posted
- 4 Jun 2015 (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.
For patients with thyroid gland nodule, fine-needle aspiration biopsy has been proved to be an efficient tool for thyroid cancer diagnosis. However, it is somewhat an invasive procedure and is subject to sampling and analysis uncertainties. Thus, improved, more reliable criteria for determining which nodule should be be aspirated are needed. Ultrasound elastography has been shown to be useful in the differential diagnosis of breast and prostate cancers. Ultrasound elastography also may discriminate malignant from benign nodule.
Detailed description
To prospectively evaluate the elastographic appearance of thyroid cancer and explore the potential sensitivity and specificity of elastography for differentiating benign and malignant tumors, with histopathologic analysis as the reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FNAB of Thyroid nodule | – | –The Patients with thyroid nodule who are scheduled for FNAB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with thyroid nodule who visit tertiary hospital for fine needle aspiration biopsy
Key inclusion criteria (1 listed)
- The patients with thyroid nodule who are supposed to take fine needle aspiration biopsy
Key exclusion criteria (1 listed)
- The patients who do not want to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of elastography using in-vivo compression for detection of thyroid cancer
Time frame: 1 year
Measuring ECI(Elasticity contrast index) of thyroid nodule by ultrasound elastography
1 secondary outcome
Determination of the parameters which could have influence on the diagnostic performance of ultrasound elastography using in-vivo compression
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- 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.
- Results publication: PubMed 22380349Luo S, Lim DJ, Kim Y. Objective ultrasound elastography scoring of thyroid nodules using spatiotemporal strain information. Med Phys. 2012 Mar;39(3):1182-9. doi: 10.1118/1.3679857.
- Results publication: PubMed 22451558Lim DJ, Luo S, Kim MH, Ko SH, Kim Y. Interobserver agreement and intraobserver reproducibility in thyroid ultrasound elastography. AJR Am J Roentgenol. 2012 Apr;198(4):896-901. doi: 10.2214/AJR.11.7009.
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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.
Dong Jun Lim, Dr. principal investigator
Associate Professor, Head, Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea
Min Hee Kim, Dr. study director
Clinical Assistant Professor, Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea
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 Elastography and Thyroid Nodule, run by Dong Jun Lim at 1 site in South Korea.
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 1 inclusion and 1 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 1 Nov 2016. 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 South Korea. 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?
Contact Dong Jun Lim, Dr. (82-2-2258-6009, ldj6026@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of elastography using in-vivo compression for detection of thyroid cancer (time frame: 1 year). 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 NCT02462512, which also lists 3 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 1 Nov 2016.