Multiparameter Ultrasound Based-AI for the Diagnosis of Thyroid Nodules

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Apr 17, 2023

Keywords

ClinConnect Summary

This study is watching whether a multiparameter ultrasound–based AI tool can help diagnose thyroid nodules. It’s an observational, forward-looking study that collects ultrasound images and related information from participants and compares the AI’s findings with results from tissue tests (pathology or cytology). The main goal is to see how nodules are classified when pathology or cytology results are available, within about four weeks.

Who can join? Adults aged 18 to 80 who have a thyroid nodule that is rated TI-RADS 3–5 (or has features like clustered micro-calcifications) and are scheduled for a fine-needle aspiration (FNA) or surgery within about one month. People with any history of invasive thyroid procedures are excluded. Participants will consent, have ultrasound imaging and standard tests, and have their thyroid function tests and pathology results recorded. The study plans to enroll up to about 2,000 people, mainly at a site in Hangzhou, China, and is expected to finish around the end of 2025. This study does not involve FDA-regulated drugs or devices, and whether the study data will be shared with participants is still being decided.

Gender

ALL

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