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

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Differentiated Thyroid Cancer

Treatments

Device: Radiofrequency (RF star electrode electrode_Fixed)

Study type

Interventional

Funder types

Other

Identifiers

NCT03416686

P170201J

Details and patient eligibility

About

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

Enrollment

18 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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