NCT03432299

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 16, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

5.3 years

First QC Date

January 22, 2018

Last Update Submit

October 25, 2022

Conditions

Papillary Thyroid MicrocarcinomaThyroid Cancer

Keywords

Thyroid DiseasesRadiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Development of 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

    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

    baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years

Study Arms (1)

RFA for PTMC

EXPERIMENTAL

Group who will undergo RFA after diagnosis of PTC

Procedure: RFA for PTMC

Interventions

RFA for PTMCPROCEDURE

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

RFA for PTMC

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39212950DERIVED

MeSH Terms

Conditions

Papillary Thyroid MicrocarcinomaThyroid NeoplasmsThyroid Diseases

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Ji-hoon Kim, MD,Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji-hoon Kim, MD,Ph.D

CONTACT

+82-2-2072-3280jihnkim@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 22, 2018

First Posted

February 14, 2018

Study Start

April 16, 2018

Primary Completion

July 31, 2023

Study Completion

December 31, 2023

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)