Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma (RFAforPTMC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03432299
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Ji-hoon Kim, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Papillary Thyroid Microcarcinoma Thyroid Cancer Procedure: RFA for PTMC Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma: Safety and Efficacy
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : November 27, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Arm Intervention/treatment
Experimental: RFA for PTMC
Group who will undergo RFA after diagnosis of PTC
Procedure: RFA for PTMC
Radiofequency ablation for papillary thyroid microcarcinoma will be performed using the system including radiofrequency generator and internally cooled electrode.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    Cervical Lymph node metastasis on Ultrasonography or other distant metastasis

  2. 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 ]
    Score on a Korean version of a thyroid-specific Quality-of-life Questionnaire Scale in Thyroid Cancer Patients

  3. 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 ]
    rate of patients who underwent potential side effects from RFA



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432299


Contacts
Layout table for location contacts
Contact: Ji-hoon Kim, MD,Ph.D +82-2-2072-3280 jihnkim@gmail.com

Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ji-hoon Kim, MD,Ph.D Seoul National University Hospital
Layout table for additonal information
Responsible Party: Ji-hoon Kim, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03432299    
Other Study ID Numbers: SNUH-RFA-PTMC
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ji-hoon Kim, Seoul National University Hospital:
Thyroid Diseases
Radiofrequency Ablation
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Neoplasms
Carcinoma, Papillary
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell