Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy (METATHYRAF)

February 23, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Radiofrequency (RF) could be technically feasible and effective in the treatment of lymph node metastases of differentiated thyroid cancer. It could constitute a minimally invasive and feasible therapeutic alternative in ambulatory, allowing a reduction of the tumoral volume sufficient to limit the symptoms even to induce a tumor remission, a normalization of the tumoral markers and a better quality of life.

The aim of this study is to evaluate the anti-tumor echographic efficacy at 12 months of radiofrequency on lymph node (LN) metastasis of thyroid cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Neuilly-sur-Seine, France
        • Hôpital Américain de Paris
      • Paris, France
        • Hôpital Laiboisière
    • Paris
      • Paris, Paris, France, 75010
        • Hopital Saint Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients over age of 18 years
  • with differentiated thyroid cancer (papillary, follicular) histologically confirmed, and absence of anaplastic component
  • Previous treatment by total thyroidectomy and cervical lymph node dissection.
  • Previous treatment by at least 1 therapeutic radioactive iodine (minimum activity 740MBq)
  • Persistence on cervical ultrasound of at least 1 cervical metastatic lymph node, visible at ultrasound, small diameter between ≥10 mm and ≤30mm, volume maximum 20ml, spotted on a picture, and confirmed by cyto-punction
  • Signed informed consent

Exclusion Criteria:

  • Location of LN metastasis with significant risk of local complication (nervous, vascular) according baseline ultrasound assessment
  • Patient carrier of a pacemaker or a defibrillator
  • Congenital or acquired hemostasis abnormality, anticoagulant therapy or double platelet antiaggregatory (aspirin and clopidogrel)
  • Hypersensitivity to local anesthetic
  • Poor general condition (performance status Eastern Cooperative Oncology Group (ECOG) > 1)
  • Survival estimated less than 12 months
  • Patient who can't follow the instructions of RF therapy or who can't be followed during 2 years in order to meet the objectives of the study
  • Non affiliation to a social security
  • Pregnant or breast feeding women at the time of RF
  • Beta hormone chorionic gonadotrope (HCG) positive test (pregnancy) before RF therapy
  • Baseline cervical ultrasound, by expert operator trained to RF, not fulfilling feasibility criteria for RF realisation because of the location of LN metastasis or the way to reach it
  • Controlateral recurrent palsy on nasofibroscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Radiofrequency
Device: Radiofrequency (RF star electrode electrode_Fixed)

The radiofrequency will be performed under ultrasound control after local anesthesia by a trained operator, after finding the lesion to be treated by the operator.

Medical device used: RF star electrode electrode_Fixed (Starmed Co,Gyeonggi-do, Korea, French representative Cosysmed).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment response.
Time Frame: 12 months

Treatment success wil; be defined on the following three criteria that should be all fulfilled

  • Loss of metastatic aspect on ultrasonography
  • LN decreased volume at least 50%
  • no vascularization in Doppler
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of patients with non-suspicious cyto-punction of treated LN at 6 months after RF
Time Frame: 6 months
6 months
Percentage of patients without any new suspicious cervical lesion
Time Frame: 3, 6, 12 and 24 months.
3, 6, 12 and 24 months.
Response time
Time Frame: within 38 months
response time for partial response, major response and disappearance of lymph node at ultrasound.
within 38 months
Reduction in thyroglobulin level in blood
Time Frame: 3, 6, 12 and 24 months
3, 6, 12 and 24 months
Reduction in thyroglobulin antibody level in blood
Time Frame: 3, 6, 12 and 24 months
3, 6, 12 and 24 months
Percentage of patient in tumor response
Time Frame: 12 and 24 months
Tumor response is defined according American Thyroid Association's criteria
12 and 24 months
Percentage of patients without any new therapeutic event
Time Frame: 12 and 24 months
12 and 24 months
Percentage of patients with good immediate tolerance
Time Frame: day 0
day 0
Percentage of (either expected or unexpected) clinical complications
Time Frame: 3, 6, 12 and 24 months
3, 6, 12 and 24 months
Percentage of patients who had a RF complete procedure
Time Frame: day 0
day 0
Percentage of patients who had a RF incomplete procedure
Time Frame: day 0
day 0
Anxiety
Time Frame: 3, 6, 12 and 24 months
visual analog scale coted by the patient
3, 6, 12 and 24 months
36-item Medical Outcomes Study Short-Form Health Survey (SF-36)
Time Frame: 3, 6, 12 and 24 months
it measures the quality of life
3, 6, 12 and 24 months
EuroQol (EQ-5D)
Time Frame: 3, 6, 12 and 24 months
EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
3, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K170202J

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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