Ultrasound-guided Thermal Ablation for Papillary Thyroid Carcinoma

February 13, 2025 updated by: Yu-kun Luo, Chinese PLA General Hospital

The Clinical Outcomes of Ultrasound-guided Thermal Ablation for the Treatment of Papillary Thyroid Carcinoma: A Multicenter Study

To evaluate long-term outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma by a multicenter study

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lin Yan, MD
  • Phone Number: 13811237313 ext 86
  • Email: gemma-y@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
          • Lin Yan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with papillary thyroid carcinoma who refuse surgery or active surveillance and choose thermal ablation

Description

Inclusion Criteria:

  1. patients age between 18 and 80 year old, both sex
  2. papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration
  3. the largest diameter ≤2.0 cm
  4. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT
  5. follow-up period ≥12 months

Exclusion Criteria:

  1. patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
  2. history of neck radiation
  3. coagulation disorder, serious heart, respiratory, liver, or renal failure
  4. dysfunction of the vocal cord on the opposite side

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of disease progression
Time Frame: through study completion, an average of 6 months
cervical lymph node metastases, recurrent tumors and persistent tumors confirmed by pathology
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of change of thyroid function
Time Frame: through study completion, an average of 6 months
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 delayed surgery
Time Frame: through study completion, an average of 1 year
patients underwent surgery after ablation because of anxiety
through study completion, an average of 1 year
Rate of complications
Time Frame: 1 week
complications of ablation
1 week
Rate of tumor disappearance
Time Frame: through study completion, an average of 6 months
complete disappearance of ablated tumor on ultrasound and contrast-enhanced ultrasound
through study completion, an average of 6 months
Rate of volume reduction
Time Frame: through study completion, an average of 6 months
volume reduction of tumor after ablation on ultrasound and contrast-enhanced ultrasound
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Yukun Luo, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

December 6, 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

Other Study ID Numbers

  • 2024-655

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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