ClinicalTrials.gg
Status unknownNCT03432299RFAforPTMCUpdated Oct 26, 2022

Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma

An interventional study of RFA for PTMC in Papillary Thyroid Microcarcinoma and Thyroid Cancer, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-10-26.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
19 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Papillary Thyroid Microcarcinoma
  • Thyroid Cancer

Keywords

  • Thyroid Diseases
  • Radiofrequency Ablation
03

In context

Papillary Thyroid Microcarcinoma

24 studies on the registry are indexed under Papillary Thyroid Microcarcinoma; 8 are open to participants now.

Browse Papillary Thyroid Microcarcinoma studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • whose thyroid cancer is 1 cm or smaller than 1 cm length
  • who does not have lymph node or distant
  • whose thyroid cancer does not have extrathyroidal extension
  • in whom it seems technically possible to completely ablate thyroid cancer using RF

Exclusion criteria

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 .
  • who has hyperthyroidism that requires treatment
  • who has bleeding tendency
  • multifocal papillary thyroid microcarcinoma
  • who is pregnant
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    RFA for PTMC

    Group who will undergo RFA after diagnosis of PTC

    Procedure: RFA for PTMC

Interventions

  • ProcedureRFA for PTMC

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

06

What researchers measure

Primary outcomes

  1. Change of tumor size

    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 outcomes

  1. Development of Metastasis

    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

  2. Change of Quality of Life

    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

  3. Incidence of potential side effects from RFA

    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

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2018 (actual). Primary completion is estimated for Jul 2023, 63 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2018
First posted
Feb 14, 2018
StartActual
Apr 16, 2018
Primary completionEst.
Jul 31, 2023
CompletionEst.
Dec 31, 2023
Last update
Oct 26, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03432299
Responsible party
Ji-hoon Kim (professor, Seoul National University Hospital) — Principal investigator
First posted
Feb 14, 2018
Start date
Apr 16, 2018
Primary completion
Jul 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Oct 26, 2022

Study contacts

Ji-hoon Kim, MD,Ph.D
Contact
jihnkim@gmail.com
+82-2-2072-3280
Ji-hoon Kim, MD,Ph.D
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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