Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy
NCT ID: NCT03416686
Last Updated: 2018-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
18 participants
INTERVENTIONAL
2018-01-31
2021-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Radiofrequency
Radiofrequency (RF star electrode electrode_Fixed)
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Radiofrequency (RF star electrode electrode_Fixed)
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Saint Louis
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Cécile Chougnet, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P170201J
Identifier Type: -
Identifier Source: org_study_id