NCT03416686

Brief 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 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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

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

December 7, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 16, 2019

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

7.1 years

First QC Date

December 7, 2017

Last Update Submit

February 23, 2026

Conditions

Differentiated Thyroid Cancer

Keywords

differentiated thyroid cancerRadiofrequency

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (14)

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

    6 months

  • Percentage of patients without any new suspicious cervical lesion

    3, 6, 12 and 24 months.

  • Response time

    within 38 months

  • Reduction in thyroglobulin level in blood

    3, 6, 12 and 24 months

  • Reduction in thyroglobulin antibody level in blood

    3, 6, 12 and 24 months

  • +9 more secondary outcomes

Study Arms (1)

Radiofrequency

EXPERIMENTAL
Device: Radiofrequency (RF star electrode electrode_Fixed)

Interventions

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).

Radiofrequency

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Saint Louis

Paris, Paris, 75010, France

Location

Hôpital Américain de Paris

Neuilly-sur-Seine, France

Location

Hôpital Laiboisière

Paris, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Radiofrequency with local anesthesia: 1 episode of treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

January 31, 2018

Study Start

April 16, 2019

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

FR(3)