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

Primary Purpose

Differentiated Thyroid Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiofrequency (RF star electrode electrode_Fixed)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Differentiated Thyroid Cancer focused on measuring differentiated thyroid cancer, Radiofrequency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Saint Louis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiofrequency

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of patients with non-suspicious cyto-punction of treated LN at 6 months after RF
Percentage of patients without any new suspicious cervical lesion
Response time
response time for partial response, major response and disappearance of lymph node at ultrasound.
Reduction in thyroglobulin level in blood
Reduction in thyroglobulin antibody level in blood
Percentage of patient in tumor response
Tumor response is defined according American Thyroid Association's criteria
Percentage of patients without any new therapeutic event
Percentage of patients with good immediate tolerance
Percentage of (either expected or unexpected) clinical complications
Percentage of patients who had a RF complete procedure
Percentage of patients who had a RF incomplete procedure
Anxiety
visual analog scale coted by the patient
36-item Medical Outcomes Study Short-Form Health Survey (SF-36)
it measures the quality of life
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.

Full Information

First Posted
December 7, 2017
Last Updated
January 30, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03416686
Brief Title
Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy
Acronym
METATHYRAF
Official Title
Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Differentiated Thyroid Cancer
Keywords
differentiated thyroid cancer, Radiofrequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Radiofrequency with local anesthesia: 1 episode of treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Radiofrequency (RF star electrode electrode_Fixed)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Treatment response.
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of patients with non-suspicious cyto-punction of treated LN at 6 months after RF
Time Frame
6 months
Title
Percentage of patients without any new suspicious cervical lesion
Time Frame
3, 6, 12 and 24 months.
Title
Response time
Description
response time for partial response, major response and disappearance of lymph node at ultrasound.
Time Frame
within 38 months
Title
Reduction in thyroglobulin level in blood
Time Frame
3, 6, 12 and 24 months
Title
Reduction in thyroglobulin antibody level in blood
Time Frame
3, 6, 12 and 24 months
Title
Percentage of patient in tumor response
Description
Tumor response is defined according American Thyroid Association's criteria
Time Frame
12 and 24 months
Title
Percentage of patients without any new therapeutic event
Time Frame
12 and 24 months
Title
Percentage of patients with good immediate tolerance
Time Frame
day 0
Title
Percentage of (either expected or unexpected) clinical complications
Time Frame
3, 6, 12 and 24 months
Title
Percentage of patients who had a RF complete procedure
Time Frame
day 0
Title
Percentage of patients who had a RF incomplete procedure
Time Frame
day 0
Title
Anxiety
Description
visual analog scale coted by the patient
Time Frame
3, 6, 12 and 24 months
Title
36-item Medical Outcomes Study Short-Form Health Survey (SF-36)
Description
it measures the quality of life
Time Frame
3, 6, 12 and 24 months
Title
EuroQol (EQ-5D)
Description
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.
Time Frame
3, 6, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile Chougnet, MD
Phone
33+142499411
Email
cecile.chougnet@aphp.fr
Facility Information:
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Chougnet, MD
Phone
33+142499411
Email
cecile.chougnet@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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