NCT03887611

Brief Summary

The application of computer-aided diagnosis (CAD) technology "S-DetectTM" enables qualitative and quantitative automated analysis of ultrasound images to obtain objective, repeatable and more accurate diagnostic results. The Elastic Contrast Factor (ECI) technique, unlike conventional strain-elastic imaging techniques, can evaluate the elastic distribution in the region of interest. The purpose of the study was to evaluate the differential diagnosis value of ultrasound S-DetectTM technology for benign and malignant thyroid nodules and evaluate the consistency of ultrasound S-DetectTM technology and sonographer in the differential diagnosis of thyroid nodules and explore the differential diagnosis value of Samsung ultrasound ECI technology for benign and malignant thyroid nodules.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 21, 2019

Last Update Submit

March 23, 2019

Conditions

Thyroid Nodule

Keywords

Artificial Intelligence; Ultrasound;Thyroid nodule; ECI

Outcome Measures

Primary Outcomes (2)

  • Benign or malignant lesions as determined by pathology

    The pathological diagnosis of benign or malignant lesions from surgery samples

    Before surgery or biopsy

  • Elastic ratio

    Clear ECI value

    Before surgery or biopsy

Study Arms (1)

thyroid nodules

Those with one or more breast nodules, age 18 or older, upcoming FNAB or surgery and signed informed consent.Those without adverse effects on the test or threatening other candidates, such as mental illness, pregnancy, poor ultrasound image quality, history of thyroid surgery or thyroid biopsy, simple cystic nodules, calcification, excessive mass or too small, the S-DetectTM system can not identify the boundary of the tumor, the basic information is incomplete.

Device: Ultrasound diagnosis

Interventions

Ultrasound diagnosisDEVICE

Ultrasound diagnosis of lesions with Samsung S-Detect and ECI technology

thyroid nodules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with thyroid nodules in large tertiary hospitals

You may qualify if:

  • Had thyroid lesions detected by ultrasound
  • Age 18 or older
  • Upcoming FNAB or surgery
  • Signing informed consent

You may not qualify if:

  • Patients who had received a biopsy of thyroid lesion before the ultrasound examination
  • Can not cooperate with the test operation
  • Patients who were pregnant or lactating
  • Patients who were undergoing neoadjuvant treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xin-Wu Cui

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (1)

  • Choi YJ, Baek JH, Park HS, Shim WH, Kim TY, Shong YK, Lee JH. A Computer-Aided Diagnosis System Using Artificial Intelligence for the Diagnosis and Characterization of Thyroid Nodules on Ultrasound: Initial Clinical Assessment. Thyroid. 2017 Apr;27(4):546-552. doi: 10.1089/thy.2016.0372. Epub 2017 Feb 28.

    PMID: 28071987RESULT

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Xin-Wu Cui, PhD,MD

    Tongji Hospital

    STUDY CHAIR

  • You-Bin Deng, PhD,MD

    Tongji Hospital

    STUDY CHAIR

Central Study Contacts

Li-Qiang Zhou, MD

CONTACT

15387076275zlq_1118@hust.edu.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 21, 2019

First Posted

March 25, 2019

Study Start

January 18, 2019

Primary Completion

January 18, 2020

Study Completion

March 18, 2020

Last Updated

March 26, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Not public because of the personal information of the participants

Locations

CN(1)