Thyroid NoduleNCT03700762
Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.
An observational study of Thyroid Nodule, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
According to the grades of echogenicity to evulated thyroid nodules is a subjective process and is thus influenced by the observer's judgement. The investigators first proposed the ultrasound gray-scale ratio (UGSR) to explore its efficacy for differentiating papillary thyroid microcarcinomas from small nodular… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- ultrasound gray-scale ratio
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 1 Oct 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients diagnosed with thyroid nodules by ultrasound or incidentally noted on other imaging tests.
Who may be able to join
- patients diagnosed as thyroid nodule.
- homo-echogenicity of normal thyroid tissue.
- able and willing to comply with all study requirements.
Who cannot join
- nodules are mainly cystic or calcified.
- pathology confirmed Hashimoto's thyroiditis.
- unable or unwilling to comply with all study requirements.
Trial locations and contacts
1 site in 1 country.
China1 site
The first people's hospital of Hangzhou
Hangzhou, Zhejiang, 310006
Chenke Xu, Doctor, 8613606503599, 113614988@qq.com
About this study
According to the grades of echogenicity to evulated thyroid nodules is a subjective process and is thus influenced by the observer's judgement. The investigators first proposed the ultrasound gray-scale ratio (UGSR) to explore its efficacy for differentiating papillary thyroid microcarcinomas from small nodular goiters.
Read the detailed description
Echogenicity is a common ultrasonic parameter to evaluate thyroid nodules. The echogenicity of the thyroid nodule was divided into 5 grades according to gray scale. Of the five categories, the diagnostic values of the hypoechoic and markedly hypoechoic categories have been widely accepted for thyroid malignant nodules. However, distinguishing between hypoechoic and markedly hypoechoic categories is a subjective process and is thus influenced by the observer's judgement. A more objective method should be proposed to differentiate papillary thyroid microcarcinoma(PTMC) from small nodular goiter(NG).
The investigators suspect the echo intensity of nodules could be reflected by values, as CT values reflecting the nodule density. The investigators first proposed the ultrasound gray-scale ratio (UGSR), namely, the ratio of lesion gray-scale value to surrounding normal thyroid tissue, and the previous study showed UGSR can better display the relationship of gray scale of PTMC or NG with surrounding normal thyroid tissue, and can make objective judgment of the nodules through quantitative results.
As the absolute ultrasound grayscale value is affected by the apparatus, scan gain, dynamic range, frequency, and operators. The investigators would collected different data acquired from different parameters to explore their potential relations.
- Conditions
- Thyroid Nodule
- Being tested
- ultrasound gray-scale ratio
- Keywords
- Thyroid Nodule, differential diagnosis
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound gray-scale ratioDiagnostic test
RADinfo radiograph reading system was used to measure the gray-scales of PTMC, NG, and thyroid tissues at the same gain level, the UGSR values of the PTMC, NG, and thyroid tissue were calculated.
| Study group | Role | What they receive |
|---|---|---|
| pathologically results | finally proved by pathologically results | |
| evaluate by ultrasound gray-scale ratio | the results confirmed by the cut-off value of ultrasound gray-scale ratio Receives: Diagnostic Test: ultrasound gray-scale ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic value of UGSR in differentiating benign from malignant thyroid nodules.
The accuracy, sensitivity and specificity of UGSR in differentiating benign from malignant thyroid nodules.
Measured: All the data will be uploaded in 1 year.
Secondary outcomes (1)
The best UGSR in differentiating benign from malignant thyroid nodules.
The cut-off value of UGSR in differentiating benign from malignant thyroid nodules.
Measured: All the data will be uploaded in 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhijiang Han, Doctor, Study director, The Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700762
- Sponsor's protocol ID
- 2018-108-01
- Status last verified
- Oct 2018
- First submitted
- 7 Jul 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.
- ClinicalTrials.gov ID
- NCT03700762
- Acronym / sponsor ID
- 2018-108-01
- Conditions
- Thyroid Nodule
- Keywords
- Thyroid Nodule, differential diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 9 Oct 2018 (actual)
- 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.
According to the grades of echogenicity to evulated thyroid nodules is a subjective process and is thus influenced by the observer's judgement. The investigators first proposed the ultrasound gray-scale ratio (UGSR) to explore its efficacy for differentiating papillary thyroid microcarcinomas from small nodular goiters.
Detailed description
Echogenicity is a common ultrasonic parameter to evaluate thyroid nodules. The echogenicity of the thyroid nodule was divided into 5 grades according to gray scale. Of the five categories, the diagnostic values of the hypoechoic and markedly hypoechoic categories have been widely accepted for thyroid malignant nodules. However, distinguishing between hypoechoic and markedly hypoechoic categories is a subjective process and is thus influenced by the observer's judgement. A more objective method should be proposed to differentiate papillary thyroid microcarcinoma(PTMC) from small nodular goiter(NG).
The investigators suspect the echo intensity of nodules could be reflected by values, as CT values reflecting the nodule density. The investigators first proposed the ultrasound gray-scale ratio (UGSR), namely, the ratio of lesion gray-scale value to surrounding normal thyroid tissue, and the previous study showed UGSR can better display the relationship of gray scale of PTMC or NG with surrounding normal thyroid tissue, and can make objective judgment of the nodules through quantitative results.
As the absolute ultrasound grayscale value is affected by the apparatus, scan gain, dynamic range, frequency, and operators. The investigators would collected different data acquired from different parameters to explore their potential relations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pathologically results | – | –finally proved by pathologically results |
| evaluate by ultrasound gray-scale ratio | – | Diagnostic Test: ultrasound gray-scale ratiothe results confirmed by the cut-off value of ultrasound gray-scale ratio |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with thyroid nodules by ultrasound or incidentally noted on other imaging tests.
Key inclusion criteria (3 listed)
- patients diagnosed as thyroid nodule.
- homo-echogenicity of normal thyroid tissue.
- able and willing to comply with all study requirements.
Key exclusion criteria (3 listed)
- nodules are mainly cystic or calcified.
- pathology confirmed Hashimoto's thyroiditis.
- unable or unwilling to comply with all study requirements.
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 |
|---|---|---|
| ultrasound gray-scale ratioRADinfo radiograph reading system was used to measure the gray-scales of PTMC, NG, and thyroid tissues at the same gain level, the UGSR values of the PTMC, NG, and thyroid tissue were calculated. | Diagnostic test | evaluate by ultrasound gray-scale ratio |
Primary outcome
The diagnostic value of UGSR in differentiating benign from malignant thyroid nodules.
Time frame: All the data will be uploaded in 1 year.
The accuracy, sensitivity and specificity of UGSR in differentiating benign from malignant thyroid nodules.
1 secondary outcome
The best UGSR in differentiating benign from malignant thyroid nodules.
Time frame: All the data will be uploaded in 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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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.
Zhijiang Han, Doctor study director
The Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
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 Thyroid Nodule, run by First People's Hospital of Hangzhou at 1 site in China.
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 3 inclusion and 3 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 9 Oct 2018. 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 China. 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 Chenke Xu, Doctor (8613606503599, 113614988@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic value of UGSR in differentiating benign from malignant thyroid nodules. (time frame: All the data will be uploaded in 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.