Ultrasound-guided Thermal Ablation for Bethesda III/IV Thyroid Nodules

Ultrasound-guided Thermal Ablation for Bethesda III/IV Thyroid Nodules: A Multicenter Study

To evaluate the long-term outcomes of ultrasound-guided thermal ablation for Bethesda III/IV thyroid nodules

Study Overview

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

Detailed Description

To evaluate and predict the long-term clinical outcomes of ultrasound-guided thermal ablation for Bethesda III/IV thyroid nodules

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Lin Yan; Phone Number: 86 13811237313; Email: gemma-y@163.com

Study Locations

• China
  • Beijing, China
    • Not yet recruiting
    • Chinese PLA General Hospital
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Lin Yan
      • Principal Investigator: Lin Yan

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

patients with Bethesda III/IV thyroid nodules

Description

Inclusion Criteria:

1. confirmation of Bethesda III or IV on fine- needle aspiration and negative on Braf V600E test
2. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT
3. refusal or ineligibility for surgery
4. follow-up time ≥12 months

Exclusion Criteria:

1. follicular neoplasm or malignancy findings on biopsy
2. no suspicious of malignancy in US
3. patients with contra-lateral vocal cord paralysis
4. follow- up time less than 12 months

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 6 months
rate of change of thyroid function	thyroid function test, including free triiodothyronine, free thyroxine, thyroid stimulating hormone, thyroid peroxidase antibody and anti-thyroglobulin antibodies	through study completion, an average of 6 months
rate of disappearance	complete disappearance of ablated nodule on ultrasound and contrast-enhanced ultrasound	through study completion, an average of 6 months
rate of complications	complications of ablation	1 week
rate of delayed surgery	patients underwent surgery after ablation because of anxiety or unsatisfactory about the volume reduction	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: Yukun Luo, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 7, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 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
• Other Study ID Numbers: 2024-656

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