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Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03700762
Recruitment Status : Unknown
Verified October 2018 by First People's Hospital of Hangzhou.
Recruitment status was:  Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
First People's Hospital of Hangzhou

Study Description
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Brief 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 goiters.

Condition or disease Intervention/treatment
Thyroid Nodule Diagnostic Test: ultrasound gray-scale ratio

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
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Diagnostic Test: ultrasound gray-scale ratio
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The best UGSR in differentiating benign from malignant thyroid nodules. [ Time Frame: All the data will be uploaded in 1 year. ]
    The cut-off value of UGSR in differentiating benign from malignant thyroid nodules.


Biospecimen Retention:   None Retained
The patients will receive fine-needle aspiration of thyroid nodules after they have completed ultrasonic image tests. The cytological tests will be furtherly carried on in pathology department to confirm the histology of thyroid lesion.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with thyroid nodules by ultrasound or incidentally noted on other imaging tests.
Criteria

Inclusion Criteria:

  • patients diagnosed as thyroid nodule.
  • homo-echogenicity of normal thyroid tissue.
  • able and willing to comply with all study requirements.

Exclusion Criteria:

  • nodules are mainly cystic or calcified.
  • pathology confirmed Hashimoto's thyroiditis.
  • unable or unwilling to comply with all study requirements.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700762


Contacts
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Contact: Chenke Xu, Doctor 8613606503599 113614988@qq.com

Locations
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China, Zhejiang
The first people's hospital of Hangzhou
Hangzhou, Zhejiang, China, 310006
Contact: Chenke Xu, Doctor    8613606503599    113614988@qq.com   
Sponsors and Collaborators
First People's Hospital of Hangzhou
Investigators
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Study Director: Zhijiang Han, Doctor The Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
More Information
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Responsible Party: First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier: NCT03700762    
Other Study ID Numbers: 2018-108-01
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First People's Hospital of Hangzhou:
Thyroid Nodule
differential diagnosis
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Thyroid Neoplasms
 Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms