Differentiated Thyroid CancerMETATHYRAFNCT03416686
Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy
A study testing Radiofrequency (RF star electrode electrode_Fixed) in people with Differentiated Thyroid Cancer, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Differentiated Thyroid Cancer
- What is being tested?
- Radiofrequency (RF star electrode electrode_Fixed)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesFrance
- Study dates
- 16 Apr 2019to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Américain de Paris
Neuilly-sur-Seine
Hôpital Saint Louis
Paris, Paris, 75010
Hôpital Laiboisière
Paris
About this study
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
- Conditions
- Differentiated Thyroid Cancer
- Being tested
- Radiofrequency (RF star electrode electrode_Fixed)
- Keywords
- differentiated thyroid cancer, Radiofrequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency (RF star electrode electrode_Fixed)Device
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).
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency | Experimental | Not described Receives: Device: Radiofrequency (RF star electrode electrode_Fixed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response.
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
Measured: 12 months
Secondary outcomes (14)
Percentage of patients with non-suspicious cyto-punction of treated LN at 6 months after RF
Measured: 6 months
Percentage of patients without any new suspicious cervical lesion
Measured: 3, 6, 12 and 24 months.
Response time
response time for partial response, major response and disappearance of lymph node at ultrasound.
Measured: within 38 months
Reduction in thyroglobulin level in blood
Measured: 3, 6, 12 and 24 months
Reduction in thyroglobulin antibody level in blood
Measured: 3, 6, 12 and 24 months
Percentage of patient in tumor response
Tumor response is defined according American Thyroid Association's criteria
Measured: 12 and 24 months
Percentage of patients without any new therapeutic event
Measured: 12 and 24 months
Percentage of patients with good immediate tolerance
Measured: day 0
Percentage of (either expected or unexpected) clinical complications
Measured: 3, 6, 12 and 24 months
Percentage of patients who had a RF complete procedure
Measured: day 0
Percentage of patients who had a RF incomplete procedure
Measured: day 0
Anxiety
visual analog scale coted by the patient
Measured: 3, 6, 12 and 24 months
36-item Medical Outcomes Study Short-Form Health Survey (SF-36)
it measures the quality of life
Measured: 3, 6, 12 and 24 months
EuroQol (EQ-5D)
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.
Measured: 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start16 Apr 2019
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Model description
- Radiofrequency with local anesthesia: 1 episode of treatment
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416686
- Sponsor's protocol ID
- K170202J
- Acronym
- METATHYRAF
- Status last verified
- Feb 2026
- First submitted
- 7 Dec 2017
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy
- ClinicalTrials.gov ID
- NCT03416686
- Acronym / sponsor ID
- METATHYRAF / K170202J
- Conditions
- Differentiated Thyroid Cancer
- Keywords
- differentiated thyroid cancer, Radiofrequency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 31 Jan 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Radiofrequency with local anesthesia: 1 episode of treatment
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency | Experimental | Device: Radiofrequency (RF star electrode electrode_Fixed) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
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 |
|---|---|---|
| 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). | Device | Radiofrequency |
Primary outcome
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
14 secondary outcomes
Percentage of patients with non-suspicious cyto-punction of treated LN at 6 months after RF
Time frame: 6 months
Percentage of patients without any new suspicious cervical lesion
Time frame: 3, 6, 12 and 24 months.
Response time
Time frame: within 38 months
Reduction in thyroglobulin level in blood
Time frame: 3, 6, 12 and 24 months
Reduction in thyroglobulin antibody level in blood
Time frame: 3, 6, 12 and 24 months
Percentage of patient in tumor response
Time frame: 12 and 24 months
Percentage of patients without any new therapeutic event
Time frame: 12 and 24 months
Percentage of patients with good immediate tolerance
Time frame: day 0
Percentage of (either expected or unexpected) clinical complications
Time frame: 3, 6, 12 and 24 months
Percentage of patients who had a RF complete procedure
Time frame: day 0
Percentage of patients who had a RF incomplete procedure
Time frame: day 0
Anxiety
Time frame: 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
EuroQol (EQ-5D)
Time frame: 3, 6, 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency (RF star electrode electrode_Fixed) in people with Differentiated Thyroid Cancer, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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 6 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.