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

Sponsor
First People's Hospital of Hangzhou (Other)
Overall Status
Unknown status
CT.gov ID
NCT03700762
Collaborator
(none)
300
1
24
12.5

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated 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.
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Oct 1, 2019
Anticipated Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. The diagnostic value of UGSR in differentiating benign from malignant thyroid nodules. [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. [All the data will be uploaded in 1 year.]

    The cut-off value of UGSR in differentiating benign from malignant thyroid nodules.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 The first people's hospital of Hangzhou Hangzhou Zhejiang China 310006

Sponsors and Collaborators

  • First People's Hospital of Hangzhou

Investigators

  • Study Director: Zhijiang Han, Doctor, The Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier:
NCT03700762
Other Study ID Numbers:
  • 2018-108-01
First Posted:
Oct 9, 2018
Last Update Posted:
Oct 9, 2018
Last Verified:
Oct 1, 2018
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 9, 2018