Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma

Thyroid Cancer Clinical Trial

— RFAforPTMC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03432299
• Other study ID #: SNUH-RFA-PTMC
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Seoul National University Hospital
• Contact: Ji-hoon Kim, MD,Ph.D
• Phone: +82-2-2072-3280
• Email: jihnkim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Papillary Thyroid Microcarcinoma
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• RFA for PTMC
Radiofequency ablation for papillary thyroid microcarcinoma will be performed using the system including radiofrequency generator and internally cooled electrode.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of tumor size	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	Development of Metastasis	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
Secondary	Change of Quality of Life	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
Secondary	Incidence of potential side effects from RFA	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