Papillary Thyroid MicrocarcinomaRFAforPTMCNCT03432299
Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma
A study testing RFA for PTMC in people with Papillary Thyroid Microcarcinoma and Thyroid Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This is a single center prospective clinical trial with regard to efficacy and safety of radiofrequency ablation of papillary thyroid microcarcinoma. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Papillary Thyroid Microcarcinoma, Thyroid Cancer
- What is being tested?
- RFA for PTMC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Apr 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
About this study
Official title: 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.
Read the 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.
- Conditions
- Papillary Thyroid Microcarcinoma, Thyroid Cancer
- Being tested
- RFA for PTMC
- Keywords
- Thyroid Diseases, Radiofrequency Ablation
- Medical subject headings
- Papillary Thyroid Microcarcinoma, Thyroid Neoplasms, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFA for PTMCProcedure or surgery
Radiofequency ablation for papillary thyroid microcarcinoma will be performed using the system including radiofrequency generator and internally cooled electrode.
| Study group | Role | What they receive |
|---|---|---|
| RFA for PTMC | Experimental | Group who will undergo RFA after diagnosis of PTC Receives: Procedure: RFA for PTMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of tumor size
Maximal dimension (mm) of ablation zone on Ultrasonography
Measured: baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
Secondary outcomes (3)
Development of Metastasis
Cervical Lymph node metastasis on Ultrasonography or other distant metastasis
Measured: 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
Score on a Korean version of a thyroid-specific Quality-of-life Questionnaire Scale in Thyroid Cancer Patients
Measured: 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
rate of patients who underwent potential side effects from RFA
Measured: baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start16 Apr 2018
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papillary Thyroid MicrocarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-hoon Kim, Seoul National University Hospital
- Investigators
- Ji-hoon Kim, MD,Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432299
- Sponsor's protocol ID
- SNUH-RFA-PTMC
- Acronym
- RFAforPTMC
- Status last verified
- Oct 2022
- First submitted
- 22 Jan 2018
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JY, Na DG, Sim JS, Sung JY, Cho SW, Park DJ, Park YJ, Kim JH. A Prospective Clinical Trial of Radiofrequency Ablation in Patients with Low-Risk Unifocal Papillary Thyroid Microcarcinoma Favoring Active Surveillance Over Surgery. Thyroid. 2024 Sep;34(9):1126-1136. doi: 10.1089/thy.2024.0098.
PubMed 39212950
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma: Safety and Efficacy
- ClinicalTrials.gov ID
- NCT03432299
- Acronym / sponsor ID
- RFAforPTMC / SNUH-RFA-PTMC
- Conditions
- Papillary Thyroid Microcarcinoma, Thyroid Cancer
- Keywords
- Thyroid Diseases, Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RFA for PTMC | Experimental | Procedure: RFA for PTMCGroup who will undergo RFA after diagnosis of PTC |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFA for PTMCRadiofequency ablation for papillary thyroid microcarcinoma will be performed using the system including radiofrequency generator and internally cooled electrode. | Procedure or surgery | RFA for PTMC |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 39212950Lee JY, Na DG, Sim JS, Sung JY, Cho SW, Park DJ, Park YJ, Kim JH. A Prospective Clinical Trial of Radiofrequency Ablation in Patients with Low-Risk Unifocal Papillary Thyroid Microcarcinoma Favoring Active Surveillance Over Surgery. Thyroid. 2024 Sep;34(9):1126-1136. doi: 10.1089/thy.2024.0098.
- Individual participant dataSharing planned: No
Related trials for Papillary Thyroid Microcarcinoma
Recruiting
Active Surveillance of Papillary Thyroid Microcarcinoma
Papillary Thyroid Microcarcinoma
Active, not recruitingPhase 2
Laser Ablation of Papillary Thyroid Microcarcinoma
Papillary Thyroid Microcarcinoma, Thyroid
RecruitingObservational study
RFA Treatment for Papillary Thyroid Microcarcinoma
Papillary Thyroid Microcarcinoma
Not yet recruiting
Decision Aid Efficacy in Low Risk Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Microcarcinoma
RecruitingObservational study
Genomic Predictors of Papillary Microcarcinoma Disease Progression
Papillary Microcarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji-hoon Kim, MD,Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFA for PTMC in people with Papillary Thyroid Microcarcinoma and Thyroid Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji-hoon Kim, MD,Ph.D (+82-2-2072-3280, jihnkim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03432299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.