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

Study Overview
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Brief Summary
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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

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

Conditions
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Differentiated Thyroid Cancer

Intervention / Treatment
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* Device: Radiofrequency (RF star electrode electrode_Fixed)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Radiofrequency with local anesthesia: 1 episode of treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency<br> | Device: Radiofrequency (RF star electrode electrode_Fixed)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | response time for partial response, major response and disappearance of lymph node at ultrasound. | 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 | 
| Percentage of patient in tumor response | Tumor response is defined according American Thyroid Association's criteria | 12 and 24 months | 
| Percentage of patients without any new therapeutic event |  | 12 and 24 months | 
| Percentage of patients with good immediate tolerance |  | day 0 | 
| Percentage of (either expected or unexpected) clinical complications |  | 3, 6, 12 and 24 months | 
| Percentage of patients who had a RF complete procedure |  | day 0 | 
| Percentage of patients who had a RF incomplete procedure |  | day 0 | 
| Anxiety | visual analog scale coted by the patient | 3, 6, 12 and 24 months | 
| 36-item Medical Outcomes Study Short-Form Health Survey (SF-36) | it measures the quality of life | 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. | 3, 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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differentiated thyroid cancer, Radiofrequency