Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma (RFAforPTMC)

October 25, 2022 updated by: Ji-hoon Kim, Seoul National University Hospital

Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma: Safety and Efficacy

This is a single center prospective clinical trial with regard to efficacy and safety of radiofrequency ablation of papillary thyroid microcarcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For treatment of papillary thyroid microcarcinoma (PTMC), radiofrequency ablation (RFA) will be performed with the supine position and neck extended under ultrasonogrphic guidance. Before RFA, local anesthesia will be performed. RFA system including radiofrequency generator (VIVA RF system, STARmed, Goyang-si, Korea) and internally cooled electrode (star RF electrode, STARmed, Goyang-si, Korea) will be used. With regard to RFA procedure, moving shot technique and hydrodissection, if indicated, will be used. After RFA, follow-up will be performed using ultrasonography, serum thyroid function test, and questionnaire for quality of life by face-to-face interview at 2 months, 6, 12, 18, 24 months during the first 2 years after RFA, and yearly afterwards.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital

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

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • who agrees to the consent form
  • aged from 19 to 60 years old
  • who has been diagnosed with Bethesda category V or VI by fine needle aspiration or needle biopsy
  • whose thyroid cancer is 1 cm or smaller than 1 cm length
  • who does not have lymph node or distant metastasis
  • whose thyroid cancer does not have extrathyroidal extension
  • in whom it seems technically possible to completely ablate thyroid cancer using RF

Exclusion Criteria:

  • who cannot routinely followed up according to the study schedule
  • who has been with Bethesda category I, II, III, or IV by fine needle aspiration or needle biopsy.
  • who has hyperthyroidism that requires treatment
  • who has bleeding tendency
  • multifocal papillary thyroid microcarcinoma
  • who is pregnant

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RFA for PTMC
Group who will undergo RFA after diagnosis of PTC
Procedure: RFA for PTMC
Radiofequency ablation for papillary thyroid microcarcinoma will be performed using the system including radiofrequency generator and internally cooled electrode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of tumor size
Time Frame: baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
Maximal dimension (mm) of ablation zone on Ultrasonography
baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of Metastasis
Time Frame: baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
Cervical Lymph node metastasis on Ultrasonography or other distant metastasis
baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
Change of Quality of Life
Time Frame: baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
Score on a Korean version of a thyroid-specific Quality-of-life Questionnaire Scale in Thyroid Cancer Patients
baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
Incidence of potential side effects from RFA
Time Frame: baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
rate of patients who underwent potential side effects from RFA
baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Ji-hoon Kim, MD,Ph.D, Seoul National University 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)

April 16, 2018

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-RFA-PTMC

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

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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