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

NCT06340945 | Recruiting

• 1 other identifier: S2023-761-01
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules;
2. 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

Conditions

Thyroid Nodules

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• rate of complications

  1 week

• cosmetic score

  through study completion, an average of 6 months

• symptom score

  through study completion, an average of 6 months

• vital volume

  through study completion, an average of 6 months

• total volume

  through study completion, an average of 6 months

Study Arms (1)

ultrasound-guided thermal ablation

EXPERIMENTAL

Procedure: ultrasound-guided thermal ablation

Interventions

ultrasound-guided thermal ablation PROCEDURE

microwave ablation, radio frequency ablation, laser ablation

ultrasound-guided thermal ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[1\]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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Lin Yan, MD.

CONTACT

8613811237313; gemma-y@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Ultrasound

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: April 2, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 19, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)