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Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma (RFAforPTMC)

Primary Purpose

Papillary Thyroid Microcarcinoma, Thyroid Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RFA for PTMC
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papillary Thyroid Microcarcinoma focused on measuring Thyroid Diseases, Radiofrequency Ablation

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RFA for PTMC

Arm Description

Group who will undergo RFA after diagnosis of PTC

Outcomes

Primary Outcome Measures

Change of tumor size
Maximal dimension (mm) of ablation zone on Ultrasonography

Secondary Outcome Measures

Development of Metastasis
Cervical Lymph node metastasis on Ultrasonography or other distant metastasis
Change of Quality of Life
Score on a Korean version of a thyroid-specific Quality-of-life Questionnaire Scale in Thyroid Cancer Patients
Incidence of potential side effects from RFA
rate of patients who underwent potential side effects from RFA

Full Information

First Posted
January 22, 2018
Last Updated
October 25, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03432299
Brief Title
Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma
Acronym
RFAforPTMC
Official Title
Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma: Safety and Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Microcarcinoma, Thyroid Cancer
Keywords
Thyroid Diseases, Radiofrequency Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RFA for PTMC
Arm Type
Experimental
Arm Description
Group who will undergo RFA after diagnosis of PTC
Intervention Type
Procedure
Intervention Name(s)
RFA for PTMC
Intervention Description
Radiofequency ablation for papillary thyroid microcarcinoma will be performed using the system including radiofrequency generator and internally cooled electrode.
Primary Outcome Measure Information:
Title
Change of tumor size
Description
Maximal dimension (mm) of ablation zone on Ultrasonography
Time Frame
baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
Secondary Outcome Measure Information:
Title
Development of Metastasis
Description
Cervical Lymph node metastasis on Ultrasonography or other distant metastasis
Time Frame
baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
Title
Change of Quality of Life
Description
Score on a Korean version of a thyroid-specific Quality-of-life Questionnaire Scale in Thyroid Cancer Patients
Time Frame
baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
Title
Incidence of potential side effects from RFA
Description
rate of patients who underwent 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-hoon Kim, MD,Ph.D
Phone
+82-2-2072-3280
Email
jihnkim@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-hoon Kim, MD,Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma

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