Multiparameter Ultrasound Based-AI for the Diagnosis of T... | NCT05816629

Studies
Multiparameter Ultrasound Based-AI for the Diagnosis of Thyroid Nodules

NCT05816629

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Apr 18, 2023Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Thyroid Nodule

Interventions

Multiparameter ultrasound based-AI

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2023Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Feb 14, 2023

First Submission Date that Met QC Criteria

Apr 17, 2023

First Posted Date

Apr 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2023

Last Update Posted Date

Apr 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The cases that fulfill the inclusion criteria will be enrolled with written informed consent. Images and videos will be collected in accordance with the procedure, uploaded to Ruiying Cloud, followed up, and registered with basic case information, such as thyroid function, FNA/surgical pathology results, etc.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multiparameter ultrasound based-AI	Diagnostic Test	Multiparameter ultrasound based-AI for the diagnosis of thyroid nodules

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with 1827 Nodule Classification	nodules with Pathology or cytopathology result	up to 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18~80 years old;
Thyroid nodules (ACR-TI RADS category 3-5，category 3 nodules ≥1cm submitted for FNA) or clustered micro-calcifications;
The patients schedule to perform FNA/surgery within 1 month;
Without any history of invasive procedure of thyroid before (such as FNA,CNB, ablation, radiation, or surgery).

Exclusion Criteria:

Incomplete data;
Contraindications of CEUS

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with thyroid nodule

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SAHZJU		Hangzhou	Zhejiang	310009	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The datasets during the current study available for participants from the sponsor on reasonable request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016606	Thyroid Nodule

Ancestor Terms

ID	Term
D013964	Thyroid Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided