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

Differentiated Thyroid Cancer Clinical Trial

— METATHYRAF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03416686
• Other study ID #: P170201J
• Status: Not yet recruiting
• Phase: N/A
• First received: December 7, 2017
• Last updated: January 30, 2018
• Start date: January 2018
• Est. completion date: February 2021

Study information

• Verified date: January 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Cécile Chougnet, MD
• Phone: 33+142499411
• Email: cecile.chougnet[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Differentiated Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Device:
• 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).

Locations

Country	Name	City	State
France	Hôpital Saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment response.	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	12 months
Secondary	Percentage of patients with non-suspicious cyto-punction of treated LN at 6 months after RF		6 months
Secondary	Percentage of patients without any new suspicious cervical lesion		3, 6, 12 and 24 months.
Secondary	Response time	response time for partial response, major response and disappearance of lymph node at ultrasound.	within 38 months
Secondary	Reduction in thyroglobulin level in blood		3, 6, 12 and 24 months
Secondary	Reduction in thyroglobulin antibody level in blood		3, 6, 12 and 24 months
Secondary	Percentage of patient in tumor response	Tumor response is defined according American Thyroid Association's criteria	12 and 24 months
Secondary	Percentage of patients without any new therapeutic event		12 and 24 months
Secondary	Percentage of patients with good immediate tolerance		day 0
Secondary	Percentage of (either expected or unexpected) clinical complications		3, 6, 12 and 24 months
Secondary	Percentage of patients who had a RF complete procedure		day 0
Secondary	Percentage of patients who had a RF incomplete procedure		day 0
Secondary	Anxiety	visual analog scale coted by the patient	3, 6, 12 and 24 months
Secondary	36-item Medical Outcomes Study Short-Form Health Survey (SF-36)	it measures the quality of life	3, 6, 12 and 24 months
Secondary	EuroQol (EQ-5D)	EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	3, 6, 12 and 24 months