Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safet… (NCT03416686) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy
France14 participantsStarted 2019-04-16
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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 f…