Status:
UNKNOWN
Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Differentiated Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 therap...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03416686
Start Date
January 1 2018
End Date
February 1 2021
Last Update
January 31 2018
Active Locations (1)
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1
Hôpital Saint Louis
Paris, France, 75010