The Outcomes of Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules

The Clinical Outcomes and Artificial Intelligence Prediction Model of Ultrasound-guided Thermal Ablation for the Treatment of Benign Thyroid Nodules：A Multicenter Prospective Study

1. To evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules;
2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of benign thyroid nodules

Study Overview

• Status: Recruiting
• Conditions: Thyroid Nodules
• Intervention / Treatment: Procedure: ultrasound-guided thermal ablation

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lin Yan, MD.; Phone Number: 8613811237313; Email: gemma-y@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• [1]confirmation of benign nodule status on two separate fine- needle aspiration (FNA) or core-needle biopsy (CNB) [2]no suspicious malignant features on ultrasound examination [3]report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation [4]refusal or ineligibility for surgery [5]follow-up time ≥6months

Exclusion Criteria:

1. follicular neoplasm or malignancy findings on biopsy
2. nodules with benign result on biopsy had suspicious of malignancy in US, including marked hypoechoic, ill-defined margins, taller-than-wide shape or microcalcifications
3. patients with cystic nodules
4. patients with contra-lateral vocal cord par- alysis
5. previous radiation to the head and neck
6. ; follow- up time less than 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ultrasound-guided thermal ablation	Procedure: ultrasound-guided thermal ablation; microwave ablation, radio frequency ablation, laser ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
volume reduction rate	The volume reduction rate (VRR)was calculated by the equations: VRR=([initial volume-final volume] × 100)/initial volume	through study completion, an average of 6 months
rate of nodule regrowth	Regrowth was defined as ≥50% volume increase compared to the previously recorded smallest volume during the follow-up	through study completion, an average of 1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of complications	complications after ablation	1 week
cosmetic score	The cosmetic score was assessed by a physician (1, no palpable mass; 2, no cosmetic problem but palpable mass; 3, a cosmetic problem on swallowing only; and 4, a readily detected cosmetic problem)	through study completion, an average of 6 months
symptom score	The symptom score was self-measured by patients using a 10-cm visual analogue scale (grade 0-10)	through study completion, an average of 6 months
vital volume	vital volume was the incompletely treated vital volume which located peripherally	through study completion, an average of 6 months
total volume	the overall volume of the nodules	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 16, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Nodule; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures; Urologic Surgical Procedures, Male; Prostatectomy; Transurethral Resection of Prostate
• Other Study ID Numbers: S2023-761-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No