Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03416686

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Differentiated Thyroid Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint Louis, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. Percentage of patients with non-suspicious cyto-punction of treated LN at 6 months after RF

    Time frame: 6 months

  2. Percentage of patients without any new suspicious cervical lesion

    Time frame: 3, 6, 12 and 24 months.

  3. Response time

    Time frame: within 38 months

    response time for partial response, major response and disappearance of lymph node at ultrasound.

  4. Reduction in thyroglobulin level in blood

    Time frame: 3, 6, 12 and 24 months

  5. Reduction in thyroglobulin antibody level in blood

    Time frame: 3, 6, 12 and 24 months

  6. Percentage of patient in tumor response

    Time frame: 12 and 24 months

    Tumor response is defined according American Thyroid Association's criteria

  7. Percentage of patients without any new therapeutic event

    Time frame: 12 and 24 months

  8. Percentage of patients with good immediate tolerance

    Time frame: day 0

  9. Percentage of (either expected or unexpected) clinical complications

    Time frame: 3, 6, 12 and 24 months

  10. Percentage of patients who had a RF complete procedure

    Time frame: day 0

  11. Percentage of patients who had a RF incomplete procedure

    Time frame: day 0

  12. Anxiety

    Time frame: 3, 6, 12 and 24 months

    visual analog scale coted by the patient

  13. 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

  14. 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: METATHYRAF

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2018
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.