Ultrasound-guided Thermal Ablation for Recurrent Thyroid Cancer

Ultrasound-guided Thermal Ablation for Recurrent Thyroid Cancer: A Multicenter Study

To evaluate the long-term outcomes of ultrasound-guided thermal ablation for recurrent thyroid cancer

Study Overview

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

Detailed Description

To evaluate and predict the long-term outcomes of ultrasound-guided thermal ablation for recurrent thyroid cancer by a multicenter study

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

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

Study Locations

• China
  • 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 recurrent thyroid cancer

Description

Inclusion Criteria:

1. patient received thyroidectomy for thyroid cancer
2. recurrent lesions were pathologically proven to be malignant by core-needle biopsy or fine needle aspiration
3. no evidence of distant metastases.
4. follow-up period ≥12 months

Exclusion Criteria:

1. coagulation disorder, serious heart, respiratory, liver, or renal failure
2. dysfunction of the vocal cord on the opposite side

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, radiofrequency ablation, laser ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of disease progression	cervical lymph node metastases and persistent tumors confirmed by pathology, Distant metastasis detected by CT, positron emission tomography, or bone scan if there were suspicious symptoms.	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of complications	complication of ablation	1 week
rate of volume reduction	volume reduction of tumor after ablation on ultrasound and contrast-enhanced ultrasound	through study completion, an average of 6 months
rate of tumor disappearance	complete disappearance of ablated tumor on ultrasound and contrast-enhanced ultrasound	through study completion, an average of 6 months
Tg level	serum thyroglobulin level	through study completion, an average of 6 months
rate of delayed surgery	patients underwent surgery after ablation because of anxiety	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; Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Recurrence; Thyroid Neoplasms
• Other Study ID Numbers: 2024-657

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