NCT03416686Active, not recruitingNot Applicable
Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy
Assistance Publique - Hôpitaux de Paris3 sites in 1 country14 target enrollmentStarted: April 16, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 14
- Locations
- 3
- Primary Endpoint
- Treatment response.
Study Overview
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 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Radiofrequency
Experimental
Intervention: Radiofrequency (RF star electrode electrode_Fixed) (Device)
Outcomes
Primary Outcomes
Treatment response.
Time Frame: 12 months
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
Secondary Outcomes
- Response time(within 38 months)
- Percentage of patient in tumor response(12 and 24 months)
- Percentage of patients who had a RF complete procedure(day 0)
- Percentage of patients with good immediate tolerance(day 0)
- Percentage of patients who had a RF incomplete procedure(day 0)
- 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.)
- 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 patients without any new therapeutic event(12 and 24 months)
- 36-item Medical Outcomes Study Short-Form Health Survey (SF-36)(3, 6, 12 and 24 months)
- Percentage of (either expected or unexpected) clinical complications(3, 6, 12 and 24 months)
- Anxiety(3, 6, 12 and 24 months)
- EuroQol (EQ-5D)(3, 6, 12 and 24 months)
Investigators
Study Sites (3)
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