Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules

NCT06729762 | Recruiting

• 1 other identifier: 2024-654
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate long-term outcomes of ultrasound-guided thermal ablation for benign thyroid nodules

Conditions

Thyroid Nodule (Benign)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• rate of nodule regrowth

  through study completion, an average of 6 months

• rate of change of thyroid function

  through study completion, an average of 6 months

Study Arms (1)

ultrasound-guided thermal ablation

ultrasound-guided thermal ablation

Procedure: ultrasound-guided thermal ablation

Interventions

ultrasound-guided thermal ablation PROCEDURE

radiofrequency ablation, microwave 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+)
• Sampling Method: Probability Sample

Study Population

patients with thyroid nodules

You may qualify if:

• confirmation of benign nodule status on two separate fine- needle aspiration or core-needle biopsy
• no suspicious malignant features on ultrasound examination
• report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation
• refusal or ineligibility for surgery
• follow-up time ≥12 months

You may not qualify if:

• follicular neoplasm or malignancy findings on biopsy
• nodules with benign result on biopsy had suspicious of malignancy in US
• patients with contra-lateral vocal cord paralysis
• previous radiation to the head and neck
• follow- up time less than 12 months

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, 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

Study Officials

• Yukun Luo

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Yan, MD

CONTACT

13811237313; gemma-y@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 11, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)