Multiparameter Ultrasound Based-AI for the Diagnosis of Thyroid Nodules
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05816629
Collaborator
(none)
2,000
1
33.4
59.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multiparameter Ultrasound Based-AI for the Diagnosis of Thyroid Nodules: an International Multi-center Study
Actual Study Start Date
:
Mar 20, 2023
Anticipated Primary Completion Date
:
Dec 31, 2025
Anticipated Study Completion Date
:
Dec 31, 2025
Outcome Measures
Primary Outcome Measures
- Number of Participants with 1827 Nodule Classification [up to 4 weeks]
nodules with Pathology or cytopathology result
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SAHZJU | Hangzhou | Zhejiang | China | 310009 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05816629
Other Study ID Numbers:
- Thyroid AI-2023
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: