NCT05816629

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.

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 Mar 2023

Typical duration for all trials

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

First Submitted

Initial submission to the registry

February 14, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 18, 2023

Status Verified

January 1, 2023

Enrollment Period

2.8 years

First QC Date

February 14, 2023

Last Update Submit

April 17, 2023

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with 1827 Nodule Classification

    nodules with Pathology or cytopathology result

    up to 4 weeks

Interventions

Multiparameter ultrasound based-AIDIAGNOSTIC_TEST

Multiparameter ultrasound based-AI for the diagnosis of thyroid nodules

Eligibility Criteria

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

patients with thyroid nodule

You may qualify if:

  • \~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).

You may not qualify if:

  • Incomplete data;
  • Contraindications of CEUS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAHZJU

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2023

First Posted

April 18, 2023

Study Start

March 20, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 18, 2023

Record last verified: 2023-01

Locations

CN(1)