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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416686
Recruitment Status : Not yet recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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


Condition or disease Intervention/treatment Phase
Differentiated Thyroid Cancer Device: Radiofrequency (RF star electrode electrode_Fixed) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Radiofrequency with local anesthesia: 1 episode of treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arm Intervention/treatment
Experimental: Radiofrequency 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).





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percentage of patients with non-suspicious cyto-punction of treated LN at 6 months after RF [ Time Frame: 6 months ]
  2. Percentage of patients without any new suspicious cervical lesion [ Time Frame: 3, 6, 12 and 24 months. ]
  3. Response time [ Time Frame: within 38 months ]
    response time for partial response, major response and disappearance of lymph node at ultrasound.

  4. Reduction in thyroglobulin level in blood [ Time Frame: 3, 6, 12 and 24 months ]
  5. Reduction in thyroglobulin antibody level in blood [ Time Frame: 3, 6, 12 and 24 months ]
  6. Percentage of patient in tumor response [ Time Frame: 12 and 24 months ]
    Tumor response is defined according American Thyroid Association's criteria

  7. Percentage of patients without any new therapeutic event [ Time Frame: 12 and 24 months ]
  8. Percentage of patients with good immediate tolerance [ Time Frame: day 0 ]
  9. Percentage of (either expected or unexpected) clinical complications [ Time Frame: 3, 6, 12 and 24 months ]
  10. Percentage of patients who had a RF complete procedure [ Time Frame: day 0 ]
  11. Percentage of patients who had a RF incomplete procedure [ Time Frame: day 0 ]
  12. Anxiety [ Time Frame: 3, 6, 12 and 24 months ]
    visual analog scale coted by the patient

  13. 36-item Medical Outcomes Study Short-Form Health Survey (SF-36) [ Time Frame: 3, 6, 12 and 24 months ]
    it measures the quality of life

  14. EuroQol (EQ-5D) [ Time Frame: 3, 6, 12 and 24 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416686


Contacts
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Contact: Cécile Chougnet, MD 33+142499411 cecile.chougnet@aphp.fr

Locations
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France
Hôpital Saint Louis
Paris, France, 75010
Contact: Cécile Chougnet, MD    33+142499411    cecile.chougnet@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03416686    
Other Study ID Numbers: P170201J
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
differentiated thyroid cancer
Radiofrequency
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms